Clearance Summary
DCATS received FDA 510(k) clearance under submission number K812799, sponsored by Dorex, 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: K812799
- Applicant / Sponsor: Dorex, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2980
- Decision date: 1981-10-20
Classification & Regulation
This clearance is catalogued under FDA product code IYM and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class III device.