Philips Holter Analysis System— 510(k) K241890
Substantially EquivalentPhilips Medizin Systeme Böblingen GmbH
FDA 510(k) clearance K241890 for Philips Holter Analysis System, Substantially Equivalent on 2025-03-21. Applicant: Philips Medizin Systeme Böblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Böblingen GmbH
- Product code
- Code MLO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Böblingen, DE
Recent devices under product code MLO
view allMore clearances from Philips Medizin Systeme Böblingen GmbH
view all- K252821 — Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
- K253654 — IntelliVue Measurement Rack 6000 (867317)
- K251702 — IntelliVue Patient Monitor MX750 +2 more
- K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
- K242962 — Telemetry Monitor 5500 Release 4.0 (867232)
Data sourced from openFDA. This site is unofficial and independent of the FDA.