Infrared Thermometer Models: DT-8806S, DT-8807S

Thermometer, Electronic, Clinical

Shenzhen Everbest Machinery Industry Co., LTD

The following data is part of a premarket notification filed by Shenzhen Everbest Machinery Industry Co., Ltd with the FDA for Infrared Thermometer Models: Dt-8806s, Dt-8807s.

Pre-market Notification Details

Device IDK203170
510k NumberK203170
Device Name:Infrared Thermometer Models: DT-8806S, DT-8807S
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Everbest Machinery Industry Co., LTD 19th Building, 5th Region, Baiwangxin Industrial Park, Songbai Rd., Baimang, Xili, Nanshan Shenzhen,  CN 518108
ContactDeng Aiguo
CorrespondentKevin Wang
Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen,  CN 518067
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-23
Decision Date2021-04-16

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