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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K151024
Device Name Finger Type Pulse Oximeter
Applicant
Taidoc Technology Corporation
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact C. W. CHEN
Correspondent
Taidoc Technology Corporation
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact SHARON PENG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/16/2015
Decision Date 03/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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