FDA 510(k)

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33

Número K: K211532 · 2022-01-19

RequerenteYibin Junxin Electronics Technology Co., Ltd.

Data da decisão2022-01-19

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 is the device name listed in this FDA 510(k) record. The listed applicant is Yibin Junxin Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K211532. 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 Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33?

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Yibin Junxin Electronics Technology Co., Ltd.. The 510(k) number is K211532.

When did Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 receive FDA 510(k) clearance?

Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 received FDA 510(k) clearance on 2022-01-19, under 510(k) number K211532.

Who is the listed applicant for Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33?

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

What is the FDA product code for Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33?

The FDA product code for Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 is DXN.

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Fonte oficial

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