Clearance Summary
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A received FDA 510(k) clearance under submission number K003565, sponsored by Agilent Technologies, 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 2000-12-20.
- Submission: K003565
- Applicant / Sponsor: Agilent Technologies, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2000-12-20
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.