FDA 510(k) Application Details - K993116

Device Classification Name Thermometer, Electronic, Clinical

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510(K) Number K993116
Device Name Thermometer, Electronic, Clinical
Applicant A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS, CA 95035 US
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Contact JERRY WANG
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Regulation Number 880.2910

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Classification Product Code FLL
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Date Received 09/20/1999
Decision Date 04/12/2000
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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