Clearance Summary
MODEL 6/60 CRT VIDEO-SONAR received FDA 510(k) clearance under submission number K760888, sponsored by Vexilar, 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 1977-02-01.
- Submission: K760888
- Applicant / Sponsor: Vexilar, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 1977-02-01
Classification & Regulation
This clearance is catalogued under FDA product code KNG and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.