Data / Medical devices / Germany / Jaeger Medical GmbH
Jaeger Medical GmbH: FDA-registered device maker in HOECHBERG Bavaria, Germany, 50 510(k) clearances
Jaeger Medical GmbH is registered with the FDA (registration 9615102) in HOECHBERG Bavaria, Germany. It lists 30 device types. The FDA files 50 510(k) clearances under its listings, the newest dated August 23, 2019. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615102
- FEI number
- 1000271197
- Address
- Leibnizstrasse 7, HOECHBERG Bavaria, Germany, 97204
- Owner or operator
- Jaeger Medical GmbH (10092652)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 3, 2025
- Registered through
- 2026
- Brand names listed
- 706960 Pressure Regulator, APS Pro, ApnoeScreen Pro, CO Test, CO2 Test, Calibration Syringe V-720254-13, Disposable Mouthpiece, Flex V-892893, Disposable Mouthpiece, Flex V-892894 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | CCJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Helium, Gaseous-Phase | BSE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Calculator, Pulmonary Function Data | BZC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Calibrator, Volume, Gas | BXW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Clip, Nose | BXJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Computer, Oxygen-Uptake | BZL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Exerciser, Measuring | ISD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, St Segment | MLC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Plethysmograph, Pressure | CCM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plethysmograph, Volume | JEH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transducer, Gas Flow | BXP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Valve, Prosthesis | ISP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| August 23, 2019 | K183567 | Vyntus/SentrySuite Product Line | BZC | Substantially Equivalent | Vyaire Medical | accessdata.fda.gov |
| August 16, 2019 | K190853 | Vyntus BODY | BZC | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| November 30, 2018 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | BZC | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| September 16, 2016 | K153654 | Sentry WEB SmartInterp | DQK | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| August 14, 2015 | K150810 | Vyntus / SentrySuite Product Line | BZC | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| March 20, 2015 | K142959 | Vyntus Walk | DQA | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| December 29, 2014 | K141936 | MICROBLAB, MICROLOOP | BZG | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| August 22, 2014 | K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE | BZC | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| November 19, 2012 | K122699 | SENTRYSUITE PRODUCT LINE | BTY | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| May 10, 2012 | K113813 | SENTRYSUITE PRODUCT LINE | BTY | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| April 13, 2012 | K113096 | MICRO I | BZG | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| October 17, 2011 | K111408 | MICROGARD II | CAH | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| August 12, 2011 | K111053 | SENTRYSUITE PRODUCT LINE | BTY | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| March 7, 2011 | K100928 | MICRO DIARY SPIROMETER | BZG | Substantially Equivalent | Viasys Respiratory Care, Inc. | accessdata.fda.gov |
| February 10, 2011 | K101873 | MASTERSCREEN IOS | BZG | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| May 18, 2009 | K081823 | MASTERSCREEN PAED - BABY BODY | CCM | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| August 20, 2008 | K080510 | VIP PULMONARY FUNCTION SYSTEM | BTY | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| April 22, 2008 | K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | JEH | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| October 10, 2007 | K072323 | MASTERSCREEN & OXYCON CPX | BZC | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| August 14, 2007 | K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE | BTY | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| December 14, 2006 | K061283 | PULMOLIFE | BZG | Substantially Equivalent | Micro Medical, Ltd. | accessdata.fda.gov |
| April 7, 2004 | K040698 | MASTERSCREEN CPX AND OXYCON CPX | BZC | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| December 1, 2003 | K031102 | MICROLAB SPIROMETER | BZG | Substantially Equivalent | Micro Direct, Inc. | accessdata.fda.gov |
| November 12, 2003 | K023120 | OXYCON MOBILE | BZC | Substantially Equivalent | Erich Jaeger GmbH | accessdata.fda.gov |
| August 27, 2003 | K030586 | MICROPEAK | BZH | Substantially Equivalent | Micro Direct, Inc. | accessdata.fda.gov |
| July 30, 2003 | K031194 | SPIROSOFT | BTY | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| March 3, 2003 | K023796 | MS PAED-BABY BODY | CCM | Substantially Equivalent | Erich Jaeger GmbH | accessdata.fda.gov |
| February 12, 2003 | K021138 | SLEEPSCREEN/APNOESCREEN CARDIO | MNR | Substantially Equivalent | Erich Jaeger GmbH | accessdata.fda.gov |
| August 2, 2001 | K012085 | SOMNO STAR & SERIES SLEEP SYSTEM | OLV | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| December 27, 2000 | K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO | MNR | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| July 12, 2000 | K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | BZC | Substantially Equivalent | Erich Jaeger GmbH | accessdata.fda.gov |
| February 22, 2000 | K992214 | OXYCON PRO | BZC | Substantially Equivalent | Erich Jaeger B.V. | accessdata.fda.gov |
| October 30, 1998 | K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES | BTY | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| April 30, 1998 | K972419 | TOENNIES NEUROSCREEN SYSTEM | IKN | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| June 17, 1997 | K965042 | MICRODL DIARYCARD SPIROMETER | BZG | Substantially Equivalent | Micro Direct, Inc. | accessdata.fda.gov |
| November 1, 1996 | K963035 | MICRO SPIROMETER | BZG | Substantially Equivalent | Micro Direct, Inc. | accessdata.fda.gov |
| October 17, 1996 | K950197 | MICROCO | CCJ | Substantially Equivalent | Micro Direct, Inc. | accessdata.fda.gov |
| February 3, 1995 | K936108 | MASTERSCREEN BODY | JEH | Substantially Equivalent | Erich Jaeger GmbH & Co. KG | accessdata.fda.gov |
| November 22, 1994 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | BTY | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| November 21, 1994 | K940375 | MICRO MPM | CAP | Substantially Equivalent | Micro Direct, Inc. | accessdata.fda.gov |
| March 7, 1994 | K933839 | MASTER SCREEN PNUEMO | BTY | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| November 24, 1993 | K934272 | SENSORMEDICS MICROGARD MICROBIAL FILTER | CAH | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| February 5, 1986 | K853434 | ERGO-PNEUMOTEST | BZL | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| September 3, 1985 | K853360 | N20 TEST | CBR | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| December 4, 1984 | K843843 | HE TEST | BSE | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| November 27, 1984 | K843855 | ERGOTEST 40 & 45 | ISP | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| November 27, 1984 | K843850 | UNIVERSAL-ERGOTEST | ISD | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| October 12, 1984 | K843847 | O2 TEST | CCL | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| October 12, 1984 | K843845 | CO TEST | CCJ | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| October 12, 1984 | K843844 | CO2 TEST | CCK | Substantially Equivalent | Erich Jaeger, 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 |
|---|---|---|---|---|---|---|
| April 8, 2024 | 94256 | Class I | Ongoing | Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Pro | Potential of the nozzle separating during patient use. | accessdata.fda.gov |
Compare with other makers
- All makers of Calculator, Pulmonary Function Data
- All makers of Spirometer, Diagnostic
- All makers of Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
- All makers of Electrocardiograph
- All makers of Monitor, St Segment
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Updated May 8, 2024. 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.