Clearance Summary
ECHO-CARDIOTRACE, AUTOMATIC received FDA 510(k) clearance under submission number K761201, sponsored by Metrix Co.. 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 1977-01-12.
- Submission: K761201
- Applicant / Sponsor: Metrix Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1977-01-12
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.