FDA 510(k) Application Details - K223044

Device Classification Name Thermometer, Electronic, Clinical

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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
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Contact Hong Xiao Lan
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Regulation Number 880.2910

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Classification Product Code FLL
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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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