Philips Medizin Systeme Böblingen GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FM | November 10, 2025 |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient M | September 2, 2025 |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | May 5, 2025 |
| K241890 | Philips Holter Analysis System | March 21, 2025 |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead E | January 17, 2025 |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | December 17, 2024 |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | February 3, 2023 |
| K211900 | Patient Information Center iX | March 4, 2022 |