Clearance Summary
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM received FDA 510(k) clearance under submission number K910194, sponsored by Puritan Bennett Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1991-05-13.
- Submission: K910194
- Applicant / Sponsor: Puritan Bennett Corp.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 1991-05-13
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.