FDA 510(k) Application Details - K130231

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K130231
Device Name Thermometer, Electronic, Clinical
Applicant JINXINBAO ELECTRONIC CO.,LTD
ROOM 404, BLDG 7, JINHUICHANG HOMELAND
LIUHONGQIAO RD.
WENZHOU, ZHEJIANG 325000 CN
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Contact HELEN NAN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 01/29/2013
Decision Date 10/15/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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