Clearance Summary
CPR PROMPT received FDA 510(k) clearance under submission number K954692, sponsored by County Line , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1996-03-27.
- Submission: K954692
- Applicant / Sponsor: County Line , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5210
- Decision date: 1996-03-27
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.