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FDA 510(k) Application Details - K172861
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K172861
Device Name
Thermometer, Electronic, Clinical
Applicant
Hangzhou Hua'an medical&health instruments Co.,Ltd
Building 2, 1# Fuzhu Nan RD, Wuchang Town, Yuhang District
Hangzhou 310023 CN
Other 510(k) Applications for this Company
Contact
Ahneo Yang
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
09/20/2017
Decision Date
12/19/2017
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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