FDA 510(k)

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

Número K: K190134 · 2019-05-20

Data da decisão2019-05-20

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2019-05-20 under 510(k) number K190134. 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 Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is a medical device that received FDA 510(k) clearance on 2019-05-20. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K190134.

When did Full Automatic (NIBP) Blood Pressure Monitor-HL158TB receive FDA 510(k) clearance?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB received FDA 510(k) clearance on 2019-05-20, under 510(k) number K190134.

Who is the listed applicant for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

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

What is the FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is DXN.

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Outros registros que listam Health & Life Co., Ltd. como candidato(a)

K211744Non-Contact Infrared Thermometer, model HL710H K211127Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM K200521Full Automatic(NIBP) Blood Pressure Monitor K190507Full Automatic (NIBP) Blood Pressure Monitor K190133Full Automatic (NIBP) Blood Pressure Monitor-HL158UB K180240Full Automatic(NIBP) Blood Pressure Monitor

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