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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K113402
Device Name SOLOHEALTH STATION
Original Applicant
SOLOHEALTH, INC.
11555 medlock bridge,
suite 190
duluth,  GA  30097
Original Contact stephen kendig
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Code
HOX  
Date Received11/17/2011
Decision Date 05/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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