Infrared Thermometer Model E127

Thermometer, Electronic, Clinical

Bioland Technology Ltd.

The following data is part of a premarket notification filed by Bioland Technology Ltd. with the FDA for Infrared Thermometer Model E127.

Pre-market Notification Details

Device IDK201161
510k NumberK201161
Device Name:Infrared Thermometer Model E127
ClassificationThermometer, Electronic, Clinical
Applicant Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen,  CN 518116
ContactYiqing Feng
CorrespondentYiqing Feng
Bioland Technology Ltd. No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen,  CN 518116
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-30
Decision Date2020-10-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06939184620008 K201161 000
06939184620008 K201161 000
06939184620008 K201161 000
06939184620008 K201161 000
06939184620008 K201161 000
06939184620008 K201161 000
06939184620008 K201161 000

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