Clearance Summary
NP15 received FDA 510(k) clearance under submission number K102515, 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 2011-03-11.
- Submission: K102515
- 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: 2011-03-11
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.