Data / Medical devices / France / Philips France

Philips France: FDA-registered device maker in Paris, France, 6 510(k) clearances

Name: Philips France FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips France is registered with the FDA (registration 3003630387) in Paris, France. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 14, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Philips France

FDA registration number: 3003630387
Address: 100 rue Reaumur, Paris, France, 75002
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Specification developer
First device listed: November 7, 2022
Registered through: 2026
Brand names listed: Capsule Surveillance System, Capsule Vitals Plus Patient Monitoring System, SmartLinx Vitals Plus Patient Monitoring System

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Specification developer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Specification developer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Specification developer	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
January 14, 2022	K213335	Capsule Surveillance System	MWI	Substantially Equivalent	Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.	accessdata.fda.gov
October 19, 2021	K210204	Capsule Vitals Plus Patient Monitoring System	MWI	Substantially Equivalent	Capsule Technologie Sas	accessdata.fda.gov
April 17, 2019	K183638	SmartLinx Vitals Plus Patient Monitoring System	MWI	Substantially Equivalent	Capsule Technologie	accessdata.fda.gov
August 8, 2018	K180734	SmartLinx Vitals Plus Patient Monitoring System	MWI	Substantially Equivalent	Capsule Technologie	accessdata.fda.gov
October 24, 2017	K171751	SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module	MWI	Substantially Equivalent	Capsule Technologie Sas	accessdata.fda.gov
September 17, 2015	K151071	SmartLinx Vitals Plus Patient Monitoring System	MWI	Substantially Equivalent	Capsule Technologie Sas	accessdata.fda.gov

Compare with other makers

Updated January 14, 2022. 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.