FDA 510(k) Application Details - K011585

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K011585
Device Name Thermometer, Electronic, Clinical
Applicant MESURE TECHNOLOGY
P.O. BOX 2249
MISSION VIEJO, CA 92690 US
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Contact PHIL ZULUETA
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 05/23/2001
Decision Date 06/13/2001
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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