Infrared Thermometer

Thermometer, Electronic, Clinical

Shandong Bittel Intelligent Technology Co., Ltd.

The following data is part of a premarket notification filed by Shandong Bittel Intelligent Technology Co., Ltd. with the FDA for Infrared Thermometer.

Pre-market Notification Details

Device IDK202368
510k NumberK202368
Device Name:Infrared Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shandong Bittel Intelligent Technology Co., Ltd. No.1 Rizhao North Road Rizhao,  CN 276800
ContactCui Shi
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-19
Decision Date2021-02-12

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