FDA 510(k) Application Details - K012037

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K012037
Device Name	Generator, Oxygen, Portable
Applicant	AIRSEP CORP. 290 CREEKSIDE DR. BUFFALO, NY 14228 US Other 510(k) Applications for this Company
Contact	CHARLOTTE H HAMILTON Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2001
Decision Date	01/17/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review