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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, body composition
510(k) Number K122388
Model 514
Device Name SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
Original Applicant
SECA GMBH & CO. KG
1300 i street, nw, 11th floor east
washington,  DC  20005 3314
Original Contact seth a mailhot
Regulation Number870.2770
Classification Product Code
MNW  
Date Received08/06/2012
Decision Date 05/02/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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