Infrared Thermometer Model Number RN-60A,RN-60B

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-60a,rn-60b.

Pre-market Notification Details

Device IDK200471
510k NumberK200471
Device Name:Infrared Thermometer Model Number RN-60A,RN-60B
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 Received2020-02-26
Decision Date2020-06-19

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.