FDA 510(k)

Wrist Type Blood Pressure Monitor (W05,W1101L)

Número K: K230409 · 2023-08-25

RequerenteShenzhen Jamr Technology Co., Ltd.

Data da decisão2023-08-25

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wrist Type Blood Pressure Monitor (W05,W1101L) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jamr Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K230409. 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 Type Blood Pressure Monitor (W05,W1101L)?

Wrist Type Blood Pressure Monitor (W05,W1101L) is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Shenzhen Jamr Technology Co., Ltd.. The 510(k) number is K230409.

When did Wrist Type Blood Pressure Monitor (W05,W1101L) receive FDA 510(k) clearance?

Wrist Type Blood Pressure Monitor (W05,W1101L) received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230409.

Who is the listed applicant for Wrist Type Blood Pressure Monitor (W05,W1101L)?

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

What is the FDA product code for Wrist Type Blood Pressure Monitor (W05,W1101L)?

The FDA product code for Wrist Type Blood Pressure Monitor (W05,W1101L) is DXN.

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Fonte oficial

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