Clearance Summary
BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 received FDA 510(k) clearance under submission number K061099, sponsored by Hoffman Laboratories, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2006-08-11.
- Submission: K061099
- Applicant / Sponsor: Hoffman Laboratories, LLC
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2006-08-11
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.