FDA 510(k) Application Details - K112929

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K112929
Device Name Thermometer, Electronic, Clinical
Applicant VISIOMED GROUP SA
21, AVENUE VICTOR HUGE
PARIS 75116 FR
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Contact ERIC SEBBAN
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 10/03/2011
Decision Date 10/18/2011
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 Y
Expedited Review



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