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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K882177
Device Name ADD-ON TO CRITICAL PATIENT CARE BED
Applicant
Cardio Systems, Inc.
P.O. Box 29923
Dallas,  TX  75229
Applicant Contact CHARLES E HASTY
Correspondent
Cardio Systems, Inc.
P.O. Box 29923
Dallas,  TX  75229
Correspondent Contact CHARLES E HASTY
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received05/24/1988
Decision Date 12/01/1988
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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