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FDA 510(k) Application Details - K172894
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K172894
Device Name
Thermometer, Electronic, Clinical
Applicant
Shenzhen Jiacom Technology Co ., Ltd
No. A6 Building, Silicon Valley Power
Qinghu Park, Longhua Street, BaoÆan Dist
Shenzhen 518109 CN
Other 510(k) Applications for this Company
Contact
Luo Tianfeng
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
09/22/2017
Decision Date
05/17/2018
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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