Clearance Summary
POCKETCPR received FDA 510(k) clearance under submission number K071321, sponsored by Bio-Detek, 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 2007-09-12.
- Submission: K071321
- Applicant / Sponsor: Bio-Detek, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5210
- Decision date: 2007-09-12
Classification & Regulation
This clearance is catalogued under FDA product code LIX and 21 CFR 870.5210, within the Cardiovascular review panel as a Class II device.