Clearance Summary
POCKET DOP 3 received FDA 510(k) clearance under submission number K910462, sponsored by Imex Medical Systems, 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 1991-06-24.
- Submission: K910462
- Applicant / Sponsor: Imex Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2660
- Decision date: 1991-06-24
Classification & Regulation
This clearance is catalogued under FDA product code HEP and 21 CFR 884.2660, within the Obstetrics/Gynecology review panel as a Class II device.