Clearance Summary
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 received FDA 510(k) clearance under submission number K022052, 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 2003-01-24.
- Submission: K022052
- Applicant / Sponsor: Northgate Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2003-01-24
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.