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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 K133588
Device Name FORA CARE BLOOD PRESSURE MONITORING SYSTEM
Applicant
FORA CARE INC.
6F, NO.127, WUGONG 2ND RD
WUGU DISTRICT
new taipei city,  TW 24888
Applicant Contact sharon peng
Correspondent
FORA CARE INC.
6F, NO.127, WUGONG 2ND RD
WUGU DISTRICT
new taipei city,  TW 24888
Correspondent Contact sharon peng
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/21/2013
Decision Date 04/25/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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