FDA 510(k)

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series

Número K: K163648 · 2017-07-07

RequerenteGrandway Technology (Shenzhen) Limited

Data da decisão2017-07-07

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K163648. 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 Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series?

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K163648.

When did Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series receive FDA 510(k) clearance?

Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series received FDA 510(k) clearance on 2017-07-07, under 510(k) number K163648.

Who is the listed applicant for Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series?

The FDA 510(k) record lists Grandway Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series?

The FDA product code for Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series is DXN.

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Outros registros que listam Grandway Technology (Shenzhen) Limited como candidato(a)

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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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