Clearance Summary
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS received FDA 510(k) clearance under submission number K020984, sponsored by Access Cardiosystems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-08-14.
- Submission: K020984
- Applicant / Sponsor: Access Cardiosystems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.5310
- Decision date: 2002-08-14
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.