Infrared Thermometer Model Number RN-50A,RN-50B

Thermometer, Electronic, Clinical

Ningbo Ranor Medical Science & Technology Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Ranor Medical Science & Technology Co., Ltd. with the FDA for Infrared Thermometer Model Number Rn-50a,rn-50b.

Pre-market Notification Details

Device IDK200578
510k NumberK200578
Device Name:Infrared Thermometer Model Number RN-50A,RN-50B
ClassificationThermometer, Electronic, Clinical
Applicant Ningbo Ranor Medical Science & Technology Co., Ltd. No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District Ningbo,  CN 315000
ContactEmma Hu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738,Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-05
Decision Date2020-07-16

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