Ear Thermometer, Model ET005, ET008, ET009

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 Ear Thermometer, Model Et005, Et008, Et009.

Pre-market Notification Details

Device IDK213084
510k NumberK213084
Device Name:Ear Thermometer, Model ET005, ET008, ET009
ClassificationThermometer, Electronic, Clinical
Applicant Guangzhou Berrcom Medical Device Co., Ltd. No.38 Huanzhen Xi Road, Dagang Town, Nansha Guangzhou,  CN 51147
ContactZhigang Du
CorrespondentYoyo Chen
Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen,  CN 518000
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-23
Decision Date2022-02-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
56947656114691 K213084 000

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