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FDA 510(k) Application Details - K152680
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K152680
Device Name
Thermometer, Electronic, Clinical
Applicant
TAIDOC TECHNOLOGY CORPORATION
6F, NO. 127, WUGONG 2ND RD
WUGU DISTRICT
NEW TAIPEI CITY 24888 TW
Other 510(k) Applications for this Company
Contact
C.W 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
09/18/2015
Decision Date
05/06/2016
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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