FDA 510(k) Application Details - K123361

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K123361
Device Name Thermometer, Electronic, Clinical
Applicant FIAB SPA
VIA COSTOLI, 4
VICCHIO
FIRENZE 50039 IT
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Contact FRANCESCO BATISTINI
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 10/31/2012
Decision Date 02/27/2013
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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