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FDA 510(k) Application Details - K203707
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K203707
Device Name
Thermometer, Electronic, Clinical
Applicant
ShenZhen ZhengKang Technology Co., Ltd.
2&3/F, Building A, No.3 FuXing Yi Lane,
HeHua Community, PingHu Street
Shenzhen 518100 CN
Other 510(k) Applications for this Company
Contact
Huayong 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
12/18/2020
Decision Date
03/12/2021
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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