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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 K101012
Device Name V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
Applicant
TaiDoc Technology Corporation
3F, 5F, NO 127 WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY,  TW 248
Applicant Contact TELING HSU
Correspondent
TaiDoc Technology Corporation
3F, 5F, NO 127 WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY,  TW 248
Correspondent Contact TELING HSU
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/12/2010
Decision Date 12/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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