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Philips Medizin Systeme Böblingen GmbH FDA Approvals
0 new drug approvals and 10 device clearances on file. This applicant is not matched to a listed company.
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A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)510(k)May 29, 2026Cardiovascular |
| IntelliVue Measurement Rack 6000 (867317)510(k)Mar 30, 2026Cardiovascular |
| IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )510(k)Nov 10, 2025Cardiovascular |
| IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)510(k)Sep 2, 2025Cardiovascular |
| Telemetry Monitor 5500 Release 4.0 (867232)510(k)May 5, 2025Cardiovascular |
| Philips Holter Analysis System510(k)Mar 21, 2025Cardiovascular |
| 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, Sn510(k)Jan 17, 2025Cardiovascular |
| Cardiac Workstation (5000); Cardiac Workstation (7000)510(k)Dec 17, 2024Cardiovascular |
| IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)510(k)Feb 3, 2023Cardiovascular |
| Patient Information Center iX510(k)Mar 4, 2022Cardiovascular |