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FDA 510(k) Application Details - K132140
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K132140
Device Name
Thermometer, Electronic, Clinical
Applicant
DUTECK INDUSTRIAL CO., LTD.
3F-2, NO. 26, 513 LANE
JUI-KUANG ROAD
TAIPEI 114 TW
Other 510(k) Applications for this Company
Contact
JOSEPH CHEN
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
07/11/2013
Decision Date
02/04/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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