FDA 510(k) Application Details - K062016

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K062016
Device Name Thermometer, Electronic, Clinical
Applicant CHOICE SMART HEALTH CARE CO. LTD.
2108 CIRO'S PLAZA
388 WEST NANJING ROAD
SHANGHAI 200003 CN
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Contact JANICE MA
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 07/17/2006
Decision Date 10/27/2006
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 Y
Expedited Review



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