Clearance Summary
ULTRASOUND B-SCANNING SYSTEM received FDA 510(k) clearance under submission number K770644, sponsored by Unirad Corp.. 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 1977-04-14.
- Submission: K770644
- Applicant / Sponsor: Unirad Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2225
- Decision date: 1977-04-14
Classification & Regulation
This clearance is catalogued under FDA product code HEM and 21 CFR 884.2225, within the Obstetrics/Gynecology review panel as a Class II device.