FDA 510(k)

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System

Número K: K182046 · 2018-11-30

Data da decisão2018-11-30

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Tyson Bioresearch, Inc.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182046. 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 Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System?

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Tyson Bioresearch, Inc.. The 510(k) number is K182046.

When did Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System receive FDA 510(k) clearance?

Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182046.

Who is the listed applicant for Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System?

The FDA 510(k) record lists Tyson Bioresearch, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System?

The FDA product code for Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Outros registros que listam Tyson Bioresearch, Inc. como candidato(a)

K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

Dispositivos Relacionados (Código: NBW)

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Fonte oficial

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