FDA 510(k) Application Details - K100495

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K100495
Device Name Thermometer, Electronic, Clinical
Applicant PHILIPS ELECTRONICS UK LIMITED
LOWER ROAD
GLEMSFORD, SUFFOLK CO10 7QS GB
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Contact MIRIAM SHARIF-MURRAY
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 02/19/2010
Decision Date 06/22/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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