Clearance Summary
PASSY-MUIR TRACH VALVE received FDA 510(k) clearance under submission number K851016, sponsored by Passy & Passy, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1985-06-07.
- Submission: K851016
- Applicant / Sponsor: Passy & Passy, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1985-06-07
Classification & Regulation
This clearance is catalogued under FDA product code BTO and 21 CFR 868.5800, within the Anesthesiology review panel as a Class II device.