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FDA 510(k) Application Details - K163518
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K163518
Device Name
Thermometer, Electronic, Clinical
Applicant
JOYTECH HEALTHCARE CO., LTD
No. 365, Wuzhou Road
Yuhang Economic Development Zone
Hangzhou 311100 CN
Other 510(k) Applications for this Company
Contact
Ren Yunhua
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
12/15/2016
Decision Date
09/19/2017
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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