Clearance Summary
HEARTSTART MRX MONITOR/DEFIBRILLATOR received FDA 510(k) clearance under submission number K062233, sponsored by Philips Medical Systems North America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-11-22.
- Submission: K062233
- Applicant / Sponsor: Philips Medical Systems North America, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2006-11-22
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.