FDA 510(k) Application Details - K172733

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K172733
Device Name Thermometer, Electronic, Clinical
Applicant TaiDoc Technology Corporation
B1-7F, No.127, Wugong 2nd Rd., Wugu District
New Taipei City 24888 TW
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Contact Sheena Song
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/11/2017
Decision Date 10/22/2018
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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