Data / Medical devices / Brazil / Philips Medical Systems Ltda
Philips Medical Systems Ltda: FDA-registered device maker in Varginha Minas Gerais, Brazil, 19 510(k) clearances
Philips Medical Systems Ltda is registered with the FDA (registration 3014541700) in Varginha Minas Gerais, Brazil. It lists 32 device types. The FDA files 19 510(k) clearances under its listings, the newest dated September 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014541700
- Address
- Avenida Otto Selgado, 250, Varginha Minas Gerais, Brazil, CEP 37066
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Specification developer
- First device listed
- October 13, 1992
- Registered through
- 2026
- Brand names listed
- 1037632 Bilichek (Advanced), 15mm Male/Female Adapter, 15mm Male/Female Adapter Low Deadspace, 40457C Chemical/Thermal Paper, 40477A Chemical/Thermal Paper, 989803138171 Defibrillator Chemical/Thermal Paper, 989803138181 Defibrillator Chemical/Thermal Paper, 989803167541 Neonatal Single-Patient NIBP Cuffs 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 2, 2025 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | MHX | Substantially Equivalent | Philips Medizin Systeme Böblingen GmbH | accessdata.fda.gov |
| July 27, 2017 | K171423 | Nasal Alar SpO2 Sensor | DQA | Substantially Equivalent | Xhale, Inc. | accessdata.fda.gov |
| November 25, 2014 | K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | HGM | Substantially Equivalent | Philips Medizin Systeme Boblingen GmbH | accessdata.fda.gov |
| September 22, 2009 | K091572 | DISPOSABLE SPO2 SENSOR M1134A | DQA | Substantially Equivalent | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | accessdata.fda.gov |
| August 21, 2009 | K092217 | MERCURY VCO2 | BZK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| December 20, 2007 | K071885 | ANTIMICROBIAL AND SINGLE-PATIENT CUFFS | OED | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| November 9, 2006 | K062605 | PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T | DQA | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| November 3, 2006 | K062455 | PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL | DQA | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| January 12, 2006 | K053174 | LOFLO C5 CO2 SENSOR | CCK | Substantially Equivalent | Respironics Novametrix, LLC | accessdata.fda.gov |
| November 17, 2005 | K052377 | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. | DQA | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| November 19, 2004 | K042601 | CAPNOSTAT 5 | CCK | Substantially Equivalent | Respironics Novametrix, Inc. | accessdata.fda.gov |
| October 15, 2004 | K042306 | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A | DQA | Substantially Equivalent | Philips Medizin Systeme Boeblingen GmbH | accessdata.fda.gov |
| February 20, 2004 | K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T | DQA | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| July 23, 2003 | K030973 | PICOSAT II SPO2 PULSE OXIMETRY MODULE | DQA | Substantially Equivalent | Philips Medical Systems | accessdata.fda.gov |
| February 24, 2003 | K023931 | PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A | HGM | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| March 19, 2001 | K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | MQM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| May 17, 2000 | K001333 | AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI | DSI | Substantially Equivalent | Agilent Technologies Deutschland GmbH | accessdata.fda.gov |
| March 23, 1998 | K971910 | MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) | DSI | Substantially Equivalent | Hewlett-Packard GmbH | accessdata.fda.gov |
| December 20, 1990 | K905101 | NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF | DXQ | Substantially Equivalent | Hewlett-Packard Co. | accessdata.fda.gov |
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Updated September 2, 2025. 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.