FDA 510(k)

Sistema de Monitoramento de Glicemia em Sangue Bioland

Número K: K191657 · 2020-03-20

Data da decisão2020-03-20

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bioland Blood Glucose Monitoring System 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 2020-03-20 under 510(k) number K191657. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bioland Blood Glucose Monitoring System?

Bioland Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K191657.

When did Bioland Blood Glucose Monitoring System receive FDA 510(k) clearance?

Bioland Blood Glucose Monitoring System received FDA 510(k) clearance on 2020-03-20, under 510(k) number K191657.

Who is the listed applicant for Bioland Blood Glucose Monitoring System?

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 Bioland Blood Glucose Monitoring System?

The FDA product code for Bioland Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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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 K201161Infrared Thermometer Model E127 K201467Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B

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Fonte oficial

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