Clearance Summary
INSUFFLATOR received FDA 510(k) clearance under submission number K812200, sponsored by Reznik Instruments. 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 1981-09-29.
- Submission: K812200
- Applicant / Sponsor: Reznik Instruments
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1981-09-29
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.