FDA 510(k) Application Details - K012217

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K012217
Device Name Thermometer, Electronic, Clinical
Applicant MEDISIM LTD.
117 AHUZAH ST.
RA'ANANNA IL
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Contact SHOSHANA FRIEDMAN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 07/16/2001
Decision Date 08/01/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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