FDA 510(k) Application Details - K032362

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K032362
Device Name Thermometer, Electronic, Clinical
Applicant MEDISIM LTD.
THE TECHNOLOGY PARK MANHAT
JERUSALEM 96251 IL
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Contact DALIA GIVONY
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 07/31/2003
Decision Date 12/04/2003
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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