INFRARED BODY THERMOMETER (Model: YK-001)

Thermometer, Electronic, Clinical

Longnan RenZhong Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Longnan Renzhong Medical Equipment Co., Ltd. with the FDA for Infrared Body Thermometer (model: Yk-001).

Pre-market Notification Details

Device IDK210118
510k NumberK210118
Device Name:INFRARED BODY THERMOMETER (Model: YK-001)
ClassificationThermometer, Electronic, Clinical
Applicant Longnan RenZhong Medical Equipment Co., Ltd. Information Industry Technology City, Longnan Economic Development Zone, Longnan Ganzhou,  CN
ContactLiangping Liao
CorrespondentIris Fung
SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, SCIENTECH Park Guangzhou Economic & Technology Development Guangzhou,  CN
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-09-15

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.