Airsep Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LMarch 28, 2011
K080348OXISCAN II DATA MANAGEMENT SYSTEMOctober 9, 2008
K020324LIFESTYLE OXYGEN CONCENTRATORMarch 13, 2002
K012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009January 17, 2002
K000963DA VINCHI EEG AND EMG/EP SYSTEMSOctober 20, 2000
K001579IMPULSE SELECTAugust 31, 2000
K001467DA VINCHI EMG/EP ISA1004EPAugust 1, 2000
K001013MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHYMay 16, 2000
K992283ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHYAugust 27, 1999
K983002MYSTIQUE ULTRASONIC NEBULIZEROctober 16, 1998
K960309AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)February 28, 1997
K962865REMBRANDT SYSTEMOctober 25, 1996
K962766AIRSEP IMPULSEOctober 10, 1996
K943207NITELIFE BI-LEVEL CPAPJuly 29, 1996
K951882ECO CHECK (ECOVALVE AND OXYGEN MONITOR)October 16, 1995
K944020AIRSEP NEWLIFE AIR OUTLET OPTIONMarch 16, 1995
K884581RELIANT OXYGEN CONCENTRATORJanuary 11, 1989
K8725344LYF OXYGEN CONCENTRATOROctober 13, 1987