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FDA 510(k) Application Details - K120671
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K120671
Device Name
Thermometer, Electronic, Clinical
Applicant
COTRONIC TECHNOLOGY LIMITED
WEST OF ZHOU SHI RD
XI XIANG ST, BAO AN ZONE
SHEN ZHEN, GUANG DONG 518126 CN
Other 510(k) Applications for this Company
Contact
TANI MOK
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
03/05/2012
Decision Date
05/17/2013
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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