Clearance Summary
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A received FDA 510(k) clearance under submission number K014157, sponsored by Philips Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-01-17.
- Submission: K014157
- Applicant / Sponsor: Philips Medical Systems
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2002-01-17
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.