FDA 510(k)

Digital Automatic Blood Pressure Monitor MD36 Series

Número K: K191593 · 2019-07-22

RequerenteGrandway Technology (Shenzhen) Limited

Data da decisão2019-07-22

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Automatic Blood Pressure Monitor MD36 Series is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K191593. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Digital Automatic Blood Pressure Monitor MD36 Series?

Digital Automatic Blood Pressure Monitor MD36 Series is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K191593.

When did Digital Automatic Blood Pressure Monitor MD36 Series receive FDA 510(k) clearance?

Digital Automatic Blood Pressure Monitor MD36 Series received FDA 510(k) clearance on 2019-07-22, under 510(k) number K191593.

Who is the listed applicant for Digital Automatic Blood Pressure Monitor MD36 Series?

The FDA 510(k) record lists Grandway Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Automatic Blood Pressure Monitor MD36 Series?

The FDA product code for Digital Automatic Blood Pressure Monitor MD36 Series is DXN.

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Outros registros que listam Grandway Technology (Shenzhen) Limited como candidato(a)

K171379Digital Automatic Wrist Blood Pressure Monitor MD4300 K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series K163679Digital Automatic Blood Pressure Monitor MD3600 K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

Dispositivos Relacionados (Código: DXN)

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