Infrared Thermometer, Model: HW-1

Thermometer, Electronic, Clinical

Dongguan SIMZO Electronic Technology Co.Ltd.

The following data is part of a premarket notification filed by Dongguan Simzo Electronic Technology Co.ltd. with the FDA for Infrared Thermometer, Model: Hw-1.

Pre-market Notification Details

Device IDK211583
510k NumberK211583
Device Name:Infrared Thermometer, Model: HW-1
ClassificationThermometer, Electronic, Clinical
Applicant Dongguan SIMZO Electronic Technology Co.Ltd. No. 6 Zhangzhou Road, Daojiao Town Dongguan,  CN 523187
ContactJinlong Wang
CorrespondentReanny Wang
Shenzhen Reanny Medical Devices Management Consulting Co. Room 1813#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen,  CN 518000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-24
Decision Date2021-09-03

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