Clearance Summary
DEVILBISS 9000 SERIES CPAP, MODEL 9001 received FDA 510(k) clearance under submission number K011229, sponsored by Sunrise Medical Hhg, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-07-11.
- Submission: K011229
- Applicant / Sponsor: Sunrise Medical Hhg, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2001-07-11
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.