Infrared Thermometer

Thermometer, Electronic, Clinical

Shandong Zhushi Pharmaceutical Group Co., Ltd.

The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd. with the FDA for Infrared Thermometer.

Pre-market Notification Details

Device IDK203454
510k NumberK203454
Device Name:Infrared Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd. No.6 Shande Road, Shan Country Heze,  CN 274300
ContactJunhui Zhu
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 Received2020-11-23
Decision Date2021-04-29

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