FDA 510(k) Application Details - K090361

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K090361
Device Name Thermometer, Electronic, Clinical
Applicant RYCOM ELECTRON TECHNOLOGY LIMITED
SUITE 8D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD (S)
SHANGHAI 200030 CN
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Contact Diana Hong
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 02/12/2009
Decision Date 10/08/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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