Medical Device Manufacturer · US , Chatsworth , CA

Hoffman Laboratories, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2005

Recent clearances: BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003, BREATHEX OMEGA CPAP DEVICE, MODEL 322

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hoffman Laboratories, LLC Anesthesiology ✕

2 devices

1-2 of 2

Cleared Aug 11, 2006

BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003

Anesthesiology · 114d

Cleared Dec 16, 2005

BREATHEX OMEGA CPAP DEVICE, MODEL 322

Anesthesiology · 86d