Medical Device Manufacturer · US , Bay Shore , NY

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

8 submissions · 8 cleared · Since 1990

Recent clearances: LUMEX AIR, AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM, ALTADYNE

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Jan 10, 1997

General Hospital · 119d

Cleared Jul 18, 1996

AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM

General Hospital · 48d

Cleared Sep 28, 1995

General Hospital · 52d

Cleared Feb 22, 1990

General Hospital · 149d