FDA 510(k) Application Details - K051233

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K051233
Device Name Thermometer, Electronic, Clinical
Applicant OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS, FL 34134 US
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Contact IWAO KOJIMA
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 05/13/2005
Decision Date 06/21/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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