Clearance Summary
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX received FDA 510(k) clearance under submission number K031504, sponsored by Koven Technology, 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 2003-07-18.
- Submission: K031504
- Applicant / Sponsor: Koven Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 2003-07-18
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.