Clearance Summary
Telemetry Monitor 5500 Release 4.0 (867232) received FDA 510(k) clearance under submission number K242962, sponsored by Philips Medizin Systeme Böblingen GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-05-05.
- Submission: K242962
- Applicant / Sponsor: Philips Medizin Systeme Böblingen GmbH
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2025-05-05
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.