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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 K122473
Device Name TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
Applicant
HILL-ROM
1069 STATE ROUTE 46 EAST
BATESVILLE,  IN  47006
Applicant Contact ANN WATERHOUSE
Correspondent
HILL-ROM
1069 STATE ROUTE 46 EAST
BATESVILLE,  IN  47006
Correspondent Contact ANN WATERHOUSE
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received08/14/2012
Decision Date 06/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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