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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 K132173
Device Name FAMILY HEALTHWARE
Applicant
SANITAS, INC.
11440 W. BERNARDO COURT, STE 300
SAN DIEGO,  CA  92027
Applicant Contact ALAN DONALD
Correspondent
SANITAS, INC.
11440 W. BERNARDO COURT, STE 300
SAN DIEGO,  CA  92027
Correspondent Contact ALAN DONALD
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/15/2013
Decision Date 05/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00164658
Reviewed by Third Party No
Combination Product No
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