Clearance Summary
PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM received FDA 510(k) clearance under submission number K935784, sponsored by Puritan-Bennett. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1994-07-13.
- Submission: K935784
- Applicant / Sponsor: Puritan-Bennett
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 1994-07-13
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.