Clearance Summary
OBSTETRICAL ULTRASOUND COMPUTER received FDA 510(k) clearance under submission number K840623, sponsored by R & S Systems. 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 1984-05-11.
- Submission: K840623
- Applicant / Sponsor: R & S Systems
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2225
- Decision date: 1984-05-11
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.