Clearance Summary
SSV PHONATE(TM) SHILEY SPEAKING VALVE received FDA 510(k) clearance under submission number K945406, sponsored by Mallinckrodt Medical Tpi, 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 1995-02-27.
- Submission: K945406
- Applicant / Sponsor: Mallinckrodt Medical Tpi, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1995-02-27
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.