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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K935837
Device Name AIRHYTHM HEALTHCARE BED
Applicant
HEALTHCARE DESIGNS
P.O. BOX 79152
SAGINAW,  TX  76179
Applicant Contact ROBERT J VON BOSE
Correspondent
HEALTHCARE DESIGNS
P.O. BOX 79152
SAGINAW,  TX  76179
Correspondent Contact ROBERT J VON BOSE
Regulation Number880.5100
Classification Product Code
FNL  
Date Received12/07/1993
Decision Date 06/21/1994
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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