FDA 510(k)

Full Automatic (NIBP) Blood Pressure Monitor

Número K: K160145 · 2016-03-13

Data da decisão2016-03-13

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Full Automatic (NIBP) Blood Pressure Monitor 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 2016-03-13 under 510(k) number K160145. 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?

Full Automatic (NIBP) Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-03-13. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K160145.

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

Full Automatic (NIBP) Blood Pressure Monitor received FDA 510(k) clearance on 2016-03-13, under 510(k) number K160145.

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

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?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor 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 K190134Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

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Dispositivos Relacionados (Código: DXN)

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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