FDA 510(k) Application Details - K120671

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K120671
Device Name Thermometer, Electronic, Clinical
Applicant COTRONIC TECHNOLOGY LIMITED
WEST OF ZHOU SHI RD
XI XIANG ST, BAO AN ZONE
SHEN ZHEN, GUANG DONG 518126 CN
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Contact TANI MOK
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 03/05/2012
Decision Date 05/17/2013
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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