FDA 510(k)

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E

Número K: K213503 · 2022-02-18

RequerenteShenzhen AOJ Medical Technology Co., Ltd.

Data da decisão2022-02-18

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K213503. 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 Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E?

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K213503.

When did Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E receive FDA 510(k) clearance?

Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E received FDA 510(k) clearance on 2022-02-18, under 510(k) number K213503.

Who is the listed applicant for Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E?

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

What is the FDA product code for Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E?

The FDA product code for Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E is DXN.

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