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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K122076
Device Name PERSONAL HEALTH CENTER (PHC)
Applicant
ADFLOW HEALTH NETWORKS INC
3232 IBIS ST
SAN DIEGO,  CA  92103
Applicant Contact Glen Feye
Correspondent
ADFLOW HEALTH NETWORKS INC
3232 IBIS ST
SAN DIEGO,  CA  92103
Correspondent Contact Glen Feye
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
MNW  
Date Received07/16/2012
Decision Date 04/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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