Clearance Summary
MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK received FDA 510(k) clearance under submission number K900271, sponsored by Digisonics, 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 1990-04-19.
- Submission: K900271
- Applicant / Sponsor: Digisonics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2225
- Decision date: 1990-04-19
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.