FDA 510(k) Application Details - K083046

Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency

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510(K) Number K083046
Device Name Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
TAIPEI COUNTY 241 TW
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Contact Yuhua Chen
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Regulation Number 870.2910

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Classification Product Code DRG
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Date Received 10/14/2008
Decision Date 01/16/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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