Clearance Summary
FETAL HEART DETECTOR #'S D102 & D102R received FDA 510(k) clearance under submission number K800858, sponsored by Sonicaid, 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 1980-05-14.
- Submission: K800858
- Applicant / Sponsor: Sonicaid, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 1980-05-14
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.