FDA 510(k) Application Details - K972022

Device Classification Name	Mattress, Air Flotation, Alternating Pressure   More FDA Info for this Device
510(K) Number	K972022
Device Name	Mattress, Air Flotation, Alternating Pressure
Applicant	CARDIO SYSTEMS, INC. 1201 NORTH INTERSTATE 35 CARROLLTON, TX 75006 US Other 510(k) Applications for this Company
Contact	MIKE A SCANLAN Other 510(k) Applications for this Contact
Regulation Number	880.5550   More FDA Info for this Regulation Number
Classification Product Code	FNM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/1997
Decision Date	01/22/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review