FDA 510(k) Application Details - K131243

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K131243
Device Name Thermometer, Electronic, Clinical
Applicant SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD
4TH FLOOR, JINHUI BLDG, NANHAI BLVD, NANSHAN DISTRICT
SHENZHEN, GUANGDON 518052 CN
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Contact FIELD FU
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 05/01/2013
Decision Date 11/12/2013
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 N
Expedited Review



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