Telemetry Monitor 5500 Release 4.0 (867232)
FDA 510(k) clearance K242962 · decided 2025-05-05
Clearance details
- K-number
- K242962
- Device name
- Telemetry Monitor 5500 Release 4.0 (867232)
- Applicant
- Philips Medizin Systeme Böblingen GmbH
- Decision
- Substantially Equivalent
- Date received
- 2024-09-25
- Decision date
- 2025-05-05
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Böblingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following syste recall (Z-2579-2026) | Philips North America Llc | 2026-06-24 |