FDA 510(k)

Infrared Thermometer (model: E201)

Número K: K213011 · 2022-04-05

Data da decisão2022-04-05

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer (model: E201) is the device name listed in this FDA 510(k) record. The listed applicant is Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2022-04-05 under 510(k) number K213011. 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 (model: E201)?

Infrared Thermometer (model: E201) is a medical device that received FDA 510(k) clearance on 2022-04-05. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K213011.

When did Infrared Thermometer (model: E201) receive FDA 510(k) clearance?

Infrared Thermometer (model: E201) received FDA 510(k) clearance on 2022-04-05, under 510(k) number K213011.

Who is the listed applicant for Infrared Thermometer (model: E201)?

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

What is the FDA product code for Infrared Thermometer (model: E201)?

The FDA product code for Infrared Thermometer (model: E201) is FLL.

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Outros registros que listam Bioland Technology, Ltd. como candidato(a)

K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System K201879Digital Thermometer Model T103, T104 K202934Blood Pressure Monitor K201161Infrared Thermometer Model E127 K201467Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B K191657Sistema de Monitoramento de Glicemia em Sangue Bioland

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Dispositivos Relacionados (Código: FLL)

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Fonte oficial

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