Clearance Summary
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A received FDA 510(k) clearance under submission number K021453, sponsored by Philips Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-07-03.
- Submission: K021453
- Applicant / Sponsor: Philips Medical Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2002-07-03
Classification & Regulation
This clearance is catalogued under FDA product code MKJ and 21 CFR 870.5310, within the Cardiovascular review panel as a Class III device.