Data / Medical devices / Finland / Ge Healthcare Finland OY
Ge Healthcare Finland OY: FDA-registered device maker in HELSINKI Uusimaa, Finland, 46 510(k) clearances
Ge Healthcare Finland OY is registered with the FDA (registration 9610105) in HELSINKI Uusimaa, Finland. It lists 47 device types. The FDA files 46 510(k) clearances under its listings, the newest dated September 1, 2026. 5 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9610105
- FEI number
- 3002806783
- Address
- Kuortaneenkatu 2, HELSINKI Uusimaa, Finland, FIN-00510
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 12, 2002
- Registered through
- 2027
- Brand names listed
- 2006644-001 SpO2 Interconnect cable, 2021406-001 SpO2 Interconnect cable, 2021406-002 SpO2 Interconnect cable, 2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only, 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in., 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in., 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in., 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2026 | K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| August 28, 2026 | K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| March 20, 2024 | K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application (Portrait CVAXB) Portrait Core Services (Portrait CSSXB) Portrait Clinical Alarming Unit (Portrait CAU01) Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) Portrait Mobile Patient Monitor Software (Portrait HSWXB) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait Wearable Pulse O | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| December 13, 2023 | K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | DQK | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| August 11, 2023 | K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services (Portrait CSS01), Portrait Clinical Alarming Unit (Portrait CAU01); Portrait Mobile Patient Monitor (Portrait HUB01), Portrait Sensor Battery (Portrait SBT01), Portrait Bedside Charger (Portrait BCH01); Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait SpO2 Attachment Accessory Band (Portrait AAB01), Portrait | MWI | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| April 6, 2023 | K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| April 13, 2022 | K213363 | CARESCAPE B450, E-musb | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| April 13, 2022 | K213336 | Carescape B850, E-musb | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| April 13, 2022 | K213181 | CARESCAPE B650, E-musb | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| April 12, 2022 | K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| October 21, 2021 | K211171 | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | CCK | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| January 29, 2020 | K191323 | Carescape B850 | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| January 24, 2020 | K191249 | CARESCAPE B450 | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| January 22, 2020 | K191322 | E-EEGX, N-EEGX | OLT | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| January 21, 2020 | K191149 | CARESCAPE B650 | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| November 12, 2015 | K150298 | Entropy Module, E-ENTROPY-01 | OLW | Substantially Equivalent | Ge Healthcare Filand OY | accessdata.fda.gov |
| February 21, 2014 | K133576 | MONITOR B40 | MHX | Substantially Equivalent | Ge Medical Systems China Co., Ltd. | accessdata.fda.gov |
| January 23, 2014 | K133622 | MAC 2000 ECG ANALYSIS SYSTEM | DPS | Substantially Equivalent | Wipro GE Healthcare | accessdata.fda.gov |
| January 16, 2014 | K132528 | E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES | DXG | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| December 4, 2013 | K132533 | CARESCAPE MONITOR B450 | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| September 27, 2013 | K132696 | TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR | DQA | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| August 28, 2013 | K131414 | CARESCAPE MONITOR B850 | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| August 28, 2013 | K131223 | CARESCAPE MONITOR B650 | MHX | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| August 2, 2011 | K103802 | TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR | DQA | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| July 19, 2011 | K103129 | ENTROPY EASYFIT SENSOR | GWQ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 17, 2011 | K103765 | MAC 600 RESTING ECG ANALYSIS SYSTEM | DPS | Substantially Equivalent | Ge Medical Systems Information Technologies, Inc. | accessdata.fda.gov |
| February 16, 2011 | K103678 | CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM | DQK | Substantially Equivalent | Ge Medical Systems Information Technologies GmbH | accessdata.fda.gov |
| October 4, 2010 | K101871 | TRUSIGNAL SPO2 FINGERTIP SENSOR | DQA | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| March 12, 2010 | K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR | DQA | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| November 28, 2008 | K082540 | GE ENTROPY SENSOR | GXY | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| July 31, 2008 | K081870 | MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO | DQA | Substantially Equivalent | GE Healthcare Finland Oy | accessdata.fda.gov |
| December 21, 2007 | K062580 | GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) | GXY | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 29, 2006 | K062576 | DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES | MHX | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 3, 2006 | K051217 | DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) | MHX | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| January 13, 2006 | K052976 | DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES | DQK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| November 22, 2005 | K052977 | DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES | DQK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 14, 2005 | K052582 | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES | CCK | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 13, 2005 | K052755 | DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT | DQA | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 23, 2005 | K052145 | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | OLW | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 5, 2005 | K051883 | DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. | OLT | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| July 15, 2005 | K051635 | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES | KOI | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 21, 2005 | K050583 | MODEL 250 SERIES MATERNAL/FETAL MONITOR | HGM | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| June 20, 2005 | K051367 | PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 | MHX | Substantially Equivalent | Ge Medical Systems Information Technologies | accessdata.fda.gov |
| May 25, 2005 | K051092 | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC | CCL | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 29, 2001 | K011000 | TRAM 2001 MODULE | MHX | Substantially Equivalent | General Electric Medical Systems Information Techn | accessdata.fda.gov |
| May 27, 1992 | K915154 | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS | CAN | Substantially Equivalent | C.G.H. Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 26, 2025 | 97786 | Class II | Ongoing | Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Record updated 3/19/26 | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. | accessdata.fda.gov |
| April 5, 2024 | 94494 | Class II | Ongoing | CARESCAPE Canvas 1000, Model Numbers: a) 5865770; b) 5865770-01040169; c) 5865770-01054142; d) 5865770-01054696; e) 5865770-01054698; f) 5865770-01054721; g) 5865770-01054740; h) 5865770-01055202; i) 5865770-01055204; j) | GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can resu | accessdata.fda.gov |
| May 19, 2023 | 92455 | Class I | Ongoing | TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. | accessdata.fda.gov |
| September 4, 2018 | 81075 | Class II | Ongoing | GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas a | When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected. | accessdata.fda.gov |
| May 25, 2018 | 80262 | Class II | Ongoing | GE Healthcare CARESCAPE Monitor B650 | When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- All makers of Computer, Diagnostic, Programmable
- All makers of Computer, Blood-Pressure
- All makers of Monitor, Breathing Frequency
- All makers of Detector And Alarm, Arrhythmia
- All makers of Alarm, Blood-Pressure
Updated September 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.