FDA 510(k) Application Details - K121696

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K121696
Device Name Thermometer, Electronic, Clinical
Applicant RALING MEDICAL COMPANY
NO. 11, HUATONG RD
BEIJING 102200 CN
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Contact WU WEI
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 06/07/2012
Decision Date 10/11/2012
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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