TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2

Bed, Flotation Therapy, Powered

HILL-ROM

The following data is part of a premarket notification filed by Hill-rom with the FDA for Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare Duo2.

Pre-market Notification Details

Device IDK122473
510k NumberK122473
Device Name:TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
ClassificationBed, Flotation Therapy, Powered
Applicant HILL-ROM 1069 STATE ROUTE 46 EAST Batesville,  IN  47006
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
HILL-ROM 1069 STATE ROUTE 46 EAST Batesville,  IN  47006
Product CodeIOQ  
CFR Regulation Number890.5170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-14
Decision Date2013-06-03
Summary:summary

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