Passy-Muir, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)September 16, 2023
K990905PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JITJune 11, 1999
K970365PASSY-MUIR O2 ADAPTER; PMA2000February 12, 1997
K962714PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV October 28, 1996
K944451PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)July 7, 1995