FDA 510(k)

Monitor de Pressão Arterial de Braço Automático AGE com modelos BA-815, BA-816, BA-818 e BA-819

Número K: K172895 · 2018-06-18

RequerenteAgeless Health Industrial Co., Ltd.

Data da decisão2018-06-18

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is the device name listed in this FDA 510(k) record. The listed applicant is Ageless Health Industrial Co., Ltd.. It received FDA 510(k) clearance on 2018-06-18 under 510(k) number K172895. 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 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is a medical device that received FDA 510(k) clearance on 2018-06-18. The listed applicant is Ageless Health Industrial Co., Ltd.. The 510(k) number is K172895.

When did AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 receive FDA 510(k) clearance?

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 received FDA 510(k) clearance on 2018-06-18, under 510(k) number K172895.

Who is the listed applicant for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

The FDA 510(k) record lists Ageless Health Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

The FDA product code for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is DXN.

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Outros registros que listam Ageless Health Industrial Co., Ltd. como candidato(a)

K172508Ageless Health Medical Digital Thermometer K153552Monitor de Pressão Arterial de Braço Automático AGE

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