FDA 510(k) Application Details - K051422

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K051422
Device Name Thermometer, Electronic, Clinical
Applicant MEDISIM LTD.
BEIT HAPA'AMON BOX 124
20 HATA'AS ST
KFAR SABA 44425 IL
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Contact AHAVA STEIN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 06/01/2005
Decision Date 09/01/2005
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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