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FDA 510(k) Application Details - K201600
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K201600
Device Name
Thermometer, Electronic, Clinical
Applicant
Kangfu Medical Equipment Factory
No.380 Ningkang East Road, Lecheng Town, Yueqing
Wenzhou 325699 CN
Other 510(k) Applications for this Company
Contact
Jixiang Zhang
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
06/12/2020
Decision Date
12/10/2021
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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