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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
Original Applicant
HILL-ROM
1069 state route 46 east
batesville,  IN  47006
Original 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 General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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