Medical Device Manufacturer · US , Buffalo , NY

Airsep Corp. - FDA 510(k) Cleared Devices

18 submissions · 17 cleared · Since 1987

Recent clearances: CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L, OXISCAN II DATA MANAGEMENT SYSTEM, LIFESTYLE OXYGEN CONCENTRATOR

18

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Airsep Corp. Anesthesiology ✕

14 devices

1-12 of 14

Cleared Mar 28, 2011

CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L

Anesthesiology · 339d

Cleared Oct 09, 2008

OXISCAN II DATA MANAGEMENT SYSTEM

Anesthesiology · 241d

Cleared Mar 13, 2002

LIFESTYLE OXYGEN CONCENTRATOR

Anesthesiology · 41d

Cleared Jan 17, 2002

HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009

Anesthesiology · 202d

Cleared Aug 31, 2000

Anesthesiology · 101d

Cleared Oct 16, 1998

MYSTIQUE ULTRASONIC NEBULIZER

Anesthesiology · 49d

Cleared Feb 28, 1997

AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)

Anesthesiology · 420d

Cleared Oct 25, 1996

REMBRANDT SYSTEM

Anesthesiology · 94d

Cleared Oct 10, 1996

Anesthesiology · 86d

Cleared Jul 29, 1996

NITELIFE BI-LEVEL CPAP

Anesthesiology · 755d

Cleared Oct 16, 1995

ECO CHECK (ECOVALVE AND OXYGEN MONITOR)

Anesthesiology · 196d

Cleared Mar 16, 1995

AIRSEP NEWLIFE AIR OUTLET OPTION

Anesthesiology · 212d