Infrared Thermometer

Thermometer, Electronic, Clinical

Shenzhen Pango Electronic Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Pango Electronic Co., Ltd with the FDA for Infrared Thermometer.

Pre-market Notification Details

Device IDK182597
510k NumberK182597
Device Name:Infrared Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Pango Electronic Co., Ltd No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village Henggang Town Shenzhen,  CN 518115
ContactYoujian Xie
CorrespondentChengyu Wang
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 Received2018-09-20
Decision Date2019-04-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50860001625832 K182597 000
00628678770188 K182597 000
10031262101249 K182597 000
G025PGIRT16020 K182597 000
00860004898610 K182597 000
00860004898627 K182597 000
00860004330691 K182597 000
00372217003021 K182597 000
00856324008297 K182597 000
00817076010952 K182597 000
06948423808763 K182597 000
06948423808817 K182597 000
06948423808824 K182597 000
00860002217222 K182597 000
00031262101358 K182597 000

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