Clearance Summary
MODEL AP 180 MINI-MONITOR received FDA 510(k) clearance under submission number K812256, 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 1981-10-20.
- Submission: K812256
- Applicant / Sponsor: Sonicaid, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 1981-10-20
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.