FDA 510(k)

Infrared Thermometer Model E127

Número K: K201161 · 2020-10-02

Data da decisão2020-10-02

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infrared Thermometer Model E127 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 2020-10-02 under 510(k) number K201161. 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 E127?

Infrared Thermometer Model E127 is a medical device that received FDA 510(k) clearance on 2020-10-02. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K201161.

When did Infrared Thermometer Model E127 receive FDA 510(k) clearance?

Infrared Thermometer Model E127 received FDA 510(k) clearance on 2020-10-02, under 510(k) number K201161.

Who is the listed applicant for Infrared Thermometer Model E127?

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 E127?

The FDA product code for Infrared Thermometer Model E127 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 K213011Infrared Thermometer (model: E201)K201879Digital Thermometer Model T103, T104 K202934Blood Pressure Monitor 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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