FDA 510(k) Application Details - K092447

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K092447
Device Name Thermometer, Electronic, Clinical
Applicant HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
BLDG 2, BAIMIAO IND. PARK
ECONOMIC DEVELOPMENT ZONE
WUCHANG, HANGZHOU, ZHEJIANG 310023 CN
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Contact JI BO
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 08/10/2009
Decision Date 01/07/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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