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FDA 510(k) Application Details - K200802
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K200802
Device Name
Thermometer, Electronic, Clinical
Applicant
Shenzhen Urion Technology Co., Ltd
4-6F of Building D, Jiale Science& Technology Industrial
Zone, Heshuikou Comm
Shenzhen 518106 CN
Other 510(k) Applications for this Company
Contact
Autumn Liu
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
03/27/2020
Decision Date
10/07/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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