Böblingen, DE · 10 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MHX | — | — | — | 5 | 2025-11-10 |
| DQA | — | — | — | 1 | 2026-05-29 |
| MSX | System, Network And Communication, Physiological Monitors | Class II | Cardiovascular | 1 | 2026-03-30 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Class II | Cardiovascular | 1 | 2025-03-21 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Class II | Cardiovascular | 1 | 2025-01-17 |
| DPS | Electrocardiograph | Class II | Cardiovascular | 1 | 2024-12-17 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-29 | K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | DQA | — | — |
| 2026-03-30 | K253654 | IntelliVue Measurement Rack 6000 (867317) | MSX | Class II | Cardiovascular |
| 2025-11-10 | K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) | MHX | — | — |
| 2025-09-02 | K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500) | MHX | — | — |
| 2025-05-05 | K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | MHX | — | — |
| 2025-03-21 | K241890 | Philips Holter Analysis System | MLO | Class II | Cardiovascular |
| 2025-01-17 | 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 | Class II | Cardiovascular |
| 2024-12-17 | K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | DPS | Class II | Cardiovascular |
| 2023-02-03 | K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) | MHX | — | — |
| 2022-03-04 | K211900 | Patient Information Center iX | MHX | — | — |