Clearance Summary
OMNIFLATOR 7640 MODEL 7-640-00 received FDA 510(k) clearance under submission number K983326, sponsored by Northgate Technologies, 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 1999-02-05.
- Submission: K983326
- Applicant / Sponsor: Northgate Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1999-02-05
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.