Clearance Summary
CARD GUARD, MODELS CG-6000 & CG-7000 received FDA 510(k) clearance under submission number K910884, sponsored by Card Guard Scientific Survival , 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 1991-10-16.
- Submission: K910884
- Applicant / Sponsor: Card Guard Scientific Survival , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 1991-10-16
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.