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FDA 510(k) Application Details - K201843
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K201843
Device Name
Thermometer, Electronic, Clinical
Applicant
Wenzhou Yosun Medical Technology Co., Ltd.
No. 17, Shahong Road, Lingmen, Beibaixiang Town, Yueqing
Wenzhou 325603 CN
Other 510(k) Applications for this Company
Contact
Lihao 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
07/06/2020
Decision Date
10/23/2020
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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