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FDA 510(k) Application Details - K193625
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K193625
Device Name
Thermometer, Electronic, Clinical
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th floor of Xiang dali Technology Park
No.87 of HengPing Road, Henggang, Longgang District
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Yahui Zhou
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
12/26/2019
Decision Date
07/24/2020
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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