Infrared Thermometer Model MD-H30

Thermometer, Electronic, Clinical

Guangzhou Berrcom Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Berrcom Medical Device Co., Ltd. with the FDA for Infrared Thermometer Model Md-h30.

Pre-market Notification Details

Device IDK191570
501k NumberK191570
Device Name:Infrared Thermometer Model MD-H30
ClassificationThermometer, Electronic, Clinical
Applicant Guangzhou Berrcom Medical Device Co., Ltd. No.38 Huanzhen Xi Road, Dagang Town, Nansha Guangzhou,  CN 511470
ContactZhigang Du
CorrespondentChristy Young
Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road, Nanshan District Shenzhen,  CN 518000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
501k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-13
Decision Date2019-11-13

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