FDA 510(k) Application Details - K081062

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K081062
Device Name	Cleaner, Air, Medical Recirculating
Applicant	AIRSONETT, INC. 6470 RIVERVIEW TERRACE FINDLEY, MN 55432 US Other 510(k) Applications for this Company
Contact	CONSTANCE G BUNDY Other 510(k) Applications for this Contact
Regulation Number	880.5045   More FDA Info for this Regulation Number
Classification Product Code	FRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2008
Decision Date	11/07/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review