FDA 510(k) Application Details - K070722

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K070722
Device Name	Cleaner, Air, Medical Recirculating
Applicant	AIRINSPACE B.V. 43795 LEE MILL SQUARE LEESBURG, VA 20176 US Other 510(k) Applications for this Company
Contact	WADE TETSUKA 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	03/15/2007
Decision Date	12/14/2007
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