Clearance Summary
CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR received FDA 510(k) clearance under submission number K920114, sponsored by Spiess Design, 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 1992-04-06.
- Submission: K920114
- Applicant / Sponsor: Spiess Design, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1992-04-06
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.