Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Airsep Corp.

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K101154	CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L	CAW	2011-03-28	View
510(k)	K080348	OXISCAN II DATA MANAGEMENT SYSTEM	DQA	2008-10-09	View
510(k)	K020324	LIFESTYLE OXYGEN CONCENTRATOR	CAW	2002-03-13	View
510(k)	K012037	HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009	CAW	2002-01-17	View
510(k)	K000963	DA VINCHI EEG AND EMG/EP SYSTEMS	GWF	2000-10-20	View
510(k)	K001579	IMPULSE SELECT	NFB	2000-08-31	View
510(k)	K001467	DA VINCHI EMG/EP ISA1004EP	GWE	2000-08-01	View
510(k)	K001013	MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY	OLV	2000-05-16	View
510(k)	K992283	ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY	OLV	1999-08-27	View
510(k)	K983002	MYSTIQUE ULTRASONIC NEBULIZER	CAF	1998-10-16	View
510(k)	K960309	AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)	CAW	1997-02-28	View
510(k)	K962865	REMBRANDT SYSTEM	FLS	1996-10-25	View
510(k)	K962766	AIRSEP IMPULSE	NFB	1996-10-10	View
510(k)	K943207	NITELIFE BI-LEVEL CPAP	BZD	1996-07-29	View
510(k)	K951882	ECO CHECK (ECOVALVE AND OXYGEN MONITOR)	CAW	1995-10-16	View
510(k)	K944020	AIRSEP NEWLIFE AIR OUTLET OPTION	CAF	1995-03-16	View
510(k)	K884581	RELIANT OXYGEN CONCENTRATOR	CAW	1989-01-11	View
510(k)	K872534	4LYF OXYGEN CONCENTRATOR	CAW	1987-10-13	View

↑