FDA 510(k) Application Details - K080759

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K080759
Device Name Thermometer, Electronic, Clinical
Applicant JXB CO. LTD GUANGZHOU (CHINA)
NO 38 HUANZHEN XI ROAD
DAGANG TOWN
PANUY, GUANGZHOU CN
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Contact TRAY CUI
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 03/18/2008
Decision Date 05/12/2008
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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