Clearance Summary
WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 received FDA 510(k) clearance under submission number K071163, sponsored by Weinmann Gerate Fur Medizin GmbH + Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2007-07-18.
- Submission: K071163
- Applicant / Sponsor: Weinmann Gerate Fur Medizin GmbH + Co. KG
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2007-07-18
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.