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FDA 510(k) Application Details - K993116
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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