FDA 510(k) Application Details - K021048

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K021048
Device Name Thermometer, Electronic, Clinical
Applicant Z7 INTERNATIONAL
34138 COURTNEY TERRACE
ACTON, CA 93510 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 04/01/2002
Decision Date 04/22/2002
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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