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FDA 510(k) Application Details - K201161
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K201161
Device Name
Thermometer, Electronic, Clinical
Applicant
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone
No. 5 Baolong Road
Shenzhen 518116 CN
Other 510(k) Applications for this Company
Contact
Yiqing Feng
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
04/30/2020
Decision Date
10/02/2020
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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