FDA 510(k) Application Details - K041664

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K041664
Device Name	Generator, Oxygen, Portable
Applicant	ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK NEWINGTON,, CT 06111 US Other 510(k) Applications for this Company
Contact	C. BART GULLONG 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	06/18/2004
Decision Date	07/29/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review