Medical Device Manufacturer · DE , Boeblingen

Philips Medizin Systeme B?blingen GmbH - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2022

Recent clearances: Reusable Adult SpO2 Clip Sensor (3m) (M1196A), IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor 6100 (6100)

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Philips Medizin Systeme B?blingen GmbH Cardiovascular ✕

8 devices

1-8 of 8

Cleared Nov 10, 2025

IntelliVue Patient Monitor MX750

Cardiovascular · 161d

Cleared Sep 02, 2025

IntelliVue Patient Monitor 6100 (6100)

Cardiovascular · 196d

Cleared May 05, 2025

Telemetry Monitor 5500 Release 4.0 (867232)

Cardiovascular · 222d

Cleared Mar 21, 2025

Philips Holter Analysis System

Cardiovascular · 266d

Cleared Jan 17, 2025

Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name:...

Cardiovascular · 63d

Cleared Dec 17, 2024

Cardiac Workstation (5000)

Cardiovascular · 200d

Cleared Feb 03, 2023

IntelliVue Patient Monitor MX750 (866471)

Cardiovascular · 270d

Cleared Mar 04, 2022

Patient Information Center iX

Cardiovascular · 256d