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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 K100427
Device Name FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY
Applicant
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 24888
Applicant Contact TELING HSU
Correspondent
Taidoc Technology Corporation
6f, # 127, Wugong 2nd Rd.
Wugu Township
New Taipei City,  TW 24888
Correspondent Contact TELING HSU
Regulation Number870.2910
Classification Product Code
DRG  
Date Received02/16/2010
Decision Date 05/28/2010
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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