FDA 510(k)

ThermArt (Model IR-EFT)

Número K: K202481 · 2021-09-28

RequerenteComper Chuangxiang (Beijing) Technology Co., Ltd.

Data da decisão2021-09-28

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ThermArt (Model IR-EFT) is the device name listed in this FDA 510(k) record. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K202481. 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 ThermArt (Model IR-EFT)?

ThermArt (Model IR-EFT) is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Comper Chuangxiang (Beijing) Technology Co., Ltd.. The 510(k) number is K202481.

When did ThermArt (Model IR-EFT) receive FDA 510(k) clearance?

ThermArt (Model IR-EFT) received FDA 510(k) clearance on 2021-09-28, under 510(k) number K202481.

Who is the listed applicant for ThermArt (Model IR-EFT)?

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

What is the FDA product code for ThermArt (Model IR-EFT)?

The FDA product code for ThermArt (Model IR-EFT) is FLL.

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Outros registros que listam Comper Chuangxiang (Beijing) Technology Co., Ltd. como candidato(a)

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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.

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