Clearance Summary
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD received FDA 510(k) clearance under submission number K090804, sponsored by Innomed Technologies, Inc./Respcare, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2009-11-05.
- Submission: K090804
- Applicant / Sponsor: Innomed Technologies, Inc./Respcare, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2009-11-05
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.