Clearance Summary
US SENSOR #CG-930P; TOCO SENSOR CG-940P received FDA 510(k) clearance under submission number K003876, 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 2001-07-09.
- Submission: K003876
- Applicant / Sponsor: Card Guard Scientific Survival , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2001-07-09
Classification & Regulation
This clearance is catalogued under FDA product code HEL and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.