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FDA 510(k) Application Details - K152640
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K152640
Device Name
Thermometer, Electronic, Clinical
Applicant
FUDAKANG INDUSTRIES CO., LTD
NO.8 YINGHE ROAD, YUANJIANGYUAN
MANAGEMENT ZONE, CHANGPING TOWN
DONGGUAN 523560 CN
Other 510(k) Applications for this Company
Contact
BOB YU
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
09/15/2015
Decision Date
03/28/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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