510(k) K242962 · MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Telemetry Monitor 5500 Release 4.0 (867232)
| Applicant | Philips Medizin Systeme Böblingen GmbH, Böblingen, DE |
| Decision | Substantially Equivalent, May 5, 2025 |
| Received | Sep 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | Philips North America Llc Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX. Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.