Clearance Summary
HI-FLO THERME PNEU 45, WISAP #7083, 7083V received FDA 510(k) clearance under submission number K031014, sponsored by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. 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 2003-06-27.
- Submission: K031014
- Applicant / Sponsor: Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2003-06-27
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.