K242962
- 510(k) number
- K242962
- Device name
- Telemetry Monitor 5500 Release 4.0 (867232)
- Applicant
- Philips Medizin Systeme Böblingen GmbH DE
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2025-05-05
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242962.pdf
Official FDA record: K242962
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.