Clearance Summary
OP-PNEU ELECTRONIC CO2 received FDA 510(k) clearance under submission number K941438, sponsored by Wisap/U.S.A.. 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 1995-05-11.
- Submission: K941438
- Applicant / Sponsor: Wisap/U.S.A.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1995-05-11
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.