Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618

Thermometer, Electronic, Clinical

Shenzhen Pango Medical Electronics Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Pango Medical Electronics Co., Ltd. with the FDA for Infrared Thermometer, Model: Pg-irt1612, Pg-irt1613, Pg-irt1615, Pg-irt1618.

Pre-market Notification Details

Device IDK212346
510k NumberK212346
Device Name:Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
ClassificationThermometer, Electronic, Clinical
Applicant Shenzhen Pango Medical Electronics Co., Ltd. No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village Henggang Town, Longgang District Shenzhen,  CN 518115
ContactYoujian Xie
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 Received2021-07-28
Decision Date2022-05-05

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