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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K934689
Device Name LOW AIR LOSS MATTRESS, MODIFICATION
Applicant
Cardio Systems, Inc.
P.O. Box 29923
Dallas,  TX  75229
Applicant Contact JOHN A CARBONA
Correspondent
Cardio Systems, Inc.
P.O. Box 29923
Dallas,  TX  75229
Correspondent Contact JOHN A CARBONA
Regulation Number890.5160
Classification Product Code
INX  
Date Received08/23/1993
Decision Date 02/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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