Philips Medizin Systeme Böblingen GmbH
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories6
Latest FDA decision2026-05-29
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | DQA | 2026-05-29 | View |
| 510(k) | K253654 | IntelliVue Measurement Rack 6000 (867317) | MSX | 2026-03-30 | View |
| 510(k) | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | MHX | 2025-11-10 | View |
| 510(k) | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | MHX | 2025-09-02 | View |
| 510(k) | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | MHX | 2025-05-05 | View |
| 510(k) | K241890 | Philips Holter Analysis System | MLO | 2025-03-21 | View |
| 510(k) | K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn | DSA | 2025-01-17 | View |
| 510(k) | K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | DPS | 2024-12-17 | View |
| 510(k) | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | MHX | 2023-02-03 | View |
| 510(k) | K211900 | Patient Information Center iX | MHX | 2022-03-04 | View |
No matching devices.