Clearance Summary
CARD GUARD MODEL CG-900 received FDA 510(k) clearance under submission number K960553, sponsored by Card Guard Scientific Survival , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1997-04-22.
- Submission: K960553
- Applicant / Sponsor: Card Guard Scientific Survival , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1997-04-22
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.