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. Chemistry ✕

2 devices

1-2 of 2

Cleared Mar 19, 2001

RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20

Chemistry · 70d

Cleared Mar 04, 1999

BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

Chemistry · 183d