FDA 510(k) Application Details - K081445

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K081445
Device Name Thermometer, Electronic, Clinical
Applicant TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 248 TW
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Contact Yuhua Chen
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 05/22/2008
Decision Date 08/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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