Medical Device Manufacturer · US , Monroeville , PA

Respironics, Inc. - FDA 510(k) Cleared Devices

173 submissions · 169 cleared · Since 1977

Recent clearances: Altis Full Face Mask, AF531 Oro-Nasal SE Face Mask, Therapy Mask 3100 NC/SP

View 173 510(k) Devices ↓ Official Website

173

Total

169

Cleared

0

Denied

FDA 510(k) Regulatory Record - Respironics, Inc. General Hospital ✕

1 devices

1-1 of 1

Cleared May 17, 1999

WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600

General Hospital · 6d