FDA 510(k)

Non-Contact Forehead Thermometer (UT30H)

Número K: K203656 · 2021-01-22

RequerenteUni-Trend Technology (China) Co., Ltd.

Data da decisão2021-01-22

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non-Contact Forehead Thermometer (UT30H) is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K203656. 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 Non-Contact Forehead Thermometer (UT30H)?

Non-Contact Forehead Thermometer (UT30H) is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. The 510(k) number is K203656.

When did Non-Contact Forehead Thermometer (UT30H) receive FDA 510(k) clearance?

Non-Contact Forehead Thermometer (UT30H) received FDA 510(k) clearance on 2021-01-22, under 510(k) number K203656.

Who is the listed applicant for Non-Contact Forehead Thermometer (UT30H)?

The FDA 510(k) record lists Uni-Trend Technology (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Contact Forehead Thermometer (UT30H)?

The FDA product code for Non-Contact Forehead Thermometer (UT30H) is FLL.

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Outros registros que listam Uni-Trend Technology (China) Co., Ltd. como candidato(a)

K203747Non-Contact Forehead Thermometer (Models UT306H & UT308H)

Dispositivos Relacionados (Código: FLL)

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