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FDA 510(k) Application Details - K210564
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K210564
Device Name
Thermometer, Electronic, Clinical
Applicant
Alicn Medical Shenzhen, Inc
Room 410, Building A, 3rd Sub-park, Leibo Zhongcheng
Life Science Park, Kengzi
Shenzhen 518118 CN
Other 510(k) Applications for this Company
Contact
Fang Meisong
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
02/25/2021
Decision Date
01/07/2022
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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