Infrared Thermometer

Thermometer, Electronic, Clinical

Shenzhen Aeon Technology Co.,Ltd.

The following data is part of a premarket notification filed by Shenzhen Aeon Technology Co.,ltd. with the FDA for Infrared Thermometer.

Pre-market Notification Details

Device IDK171578
510k NumberK171578
Device Name:Infrared Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Aeon Technology Co.,Ltd. East 5/F, Block 15 Industrial Zone Of Majialong Nanshan District Shenzhen,  CN 51800
ContactApplicant Wendy
CorrespondentMei Tan
Chonconn Medical Device Consulting Co., Ltd. 22A, Haijing Square, No. 18, Taizi Road, Nanshan District Shenzhen,  CN 51800
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-31
Decision Date2017-11-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10818323023548 K171578 000
06947832500282 K171578 000
06947832500138 K171578 000
36947832500092 K171578 000
00810477022197 K171578 000
00810477021558 K171578 000
00810477022838 K171578 000
00810477023637 K171578 000

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