FDA 510(k) Application Details - K131155

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K131155
Device Name Thermometer, Electronic, Clinical
Applicant MEDISIM LTD.
G.G. COMMUNICATIONS CENTER
NEVE IIAN
JERUSALEM 90850 IL
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Contact MOSHE YARDEN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 04/24/2013
Decision Date 08/28/2013
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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