FDA 510(k) Application Details - K981337

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K981337
Device Name Thermometer, Electronic, Clinical
Applicant MESURE TECHNOLOGY
26792 VIA ALCALA
MISSION VIEJO, CA 92691-3432 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 04/13/1998
Decision Date 09/30/1998
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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