Medical Device Manufacturer · US , Mccordsville , IN

Profile Therapeutics Plc - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2004

Recent clearances: I-NEB INSIGHT AAD SYSTEM, I-NEB AAD SYSTEM, PRODOSE AAD SYSTEM

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Profile Therapeutics Plc Anesthesiology ✕

3 devices

1-3 of 3

Cleared Dec 09, 2005

I-NEB INSIGHT AAD SYSTEM

Anesthesiology · 50d

Cleared Sep 23, 2005

I-NEB AAD SYSTEM

Anesthesiology · 326d

Cleared Apr 22, 2004

PRODOSE AAD SYSTEM

Anesthesiology · 409d