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FDA 510(k)

Infrared Forehead Thermometer

Número K: K201536 · 2021-02-10

RequerenteHangzhou Qingyuan Medical Equipment Technology Co., Ltd.
Data da decisão2021-02-10
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-10 under 510(k) number K201536. 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 Forehead Thermometer?

Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.. The 510(k) number is K201536.

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

Infrared Forehead Thermometer received FDA 510(k) clearance on 2021-02-10, under 510(k) number K201536.

Who is the listed applicant for Infrared Forehead Thermometer?

The FDA 510(k) record lists Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer?

The FDA product code for Infrared Forehead Thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

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