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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K926403
Device Name PRO-2000 LOW AIR LOSS THERAPY BED
Applicant
Ch Administration, Inc.
P.O. Box 29923
Dallas,  TX  75229
Applicant Contact JOHN A CARBONA
Correspondent
Ch Administration, Inc.
P.O. Box 29923
Dallas,  TX  75229
Correspondent Contact JOHN A CARBONA
Regulation Number880.5550
Classification Product Code
FNM  
Date Received12/21/1992
Decision Date 07/30/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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