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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 K110044
Device Name FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM
Applicant
Foracare, Inc.
3f, 5f, 6f, #127, Wugong
2nd Rd., Wugu Township
Taipei County,  TW 24888
Applicant Contact TELING HSU
Correspondent
Foracare, Inc.
3f, 5f, 6f, #127, Wugong
2nd Rd., Wugu Township
Taipei County,  TW 24888
Correspondent Contact TELING HSU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/06/2011
Decision Date 07/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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