Clearance Summary
BREATHEX OMEGA CPAP DEVICE, MODEL 322 received FDA 510(k) clearance under submission number K052597, 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 2005-12-16.
- Submission: K052597
- Applicant / Sponsor: Hoffman Laboratories, LLC
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2005-12-16
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.