FDA 510(k)

Infrared Thermometer

Número K: K211752 · 2022-01-21

RequerenteBeijing Choice Electronic Technology Co., Ltd.

Data da decisão2022-01-21

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K211752. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infrared Thermometer?

Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K211752.

When did Infrared Thermometer receive FDA 510(k) clearance?

Infrared Thermometer received FDA 510(k) clearance on 2022-01-21, under 510(k) number K211752.

Who is the listed applicant for Infrared Thermometer?

The FDA 510(k) record lists Beijing Choice Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer?

The FDA product code for Infrared Thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Fonte oficial

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