FDA 510(k) Application Details - K072641

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K072641
Device Name Thermometer, Electronic, Clinical
Applicant FAMIDOC TECHNOLOGY CO., LTD
6/F,G BUILDING 14 LIUXIAN 1ST
RD 71 BLOCK BAOAN DISTRICT
SHENZHEN GUANGDONG,PR CN
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Contact STEELJIN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/18/2007
Decision Date 11/01/2007
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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