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FDA 510(k) Application Details - K223044
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K223044
Device Name
Thermometer, Electronic, Clinical
Applicant
Shen Zhen Rong Feng Technology Co., Ltd
3/F R Building ShaSi Industrial Park, Shajing Town
BaoAn district
Shenzhen CN
Other 510(k) Applications for this Company
Contact
Hong Xiao Lan
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
09/29/2022
Decision Date
05/10/2023
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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