Clearance Summary
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER received FDA 510(k) clearance under submission number K982651, sponsored by Corometrics Medical Systems, Inc.. 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 1998-12-11.
- Submission: K982651
- Applicant / Sponsor: Corometrics Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 1998-12-11
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.