FDA 510(k) Application Details - K122221

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K122221
Device Name Thermometer, Electronic, Clinical
Applicant TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City 24888 TW
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Contact PINJUNG CHEN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 07/25/2012
Decision Date 03/29/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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