FDA 510(k)

Digital Automatic Wrist Blood Pressure Monitor MD4300

Número K: K171379 · 2018-04-10

RequerenteGrandway Technology (Shenzhen) Limited

Data da decisão2018-04-10

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Automatic Wrist Blood Pressure Monitor MD4300 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 2018-04-10 under 510(k) number K171379. 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 Wrist Blood Pressure Monitor MD4300?

Digital Automatic Wrist Blood Pressure Monitor MD4300 is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K171379.

When did Digital Automatic Wrist Blood Pressure Monitor MD4300 receive FDA 510(k) clearance?

Digital Automatic Wrist Blood Pressure Monitor MD4300 received FDA 510(k) clearance on 2018-04-10, under 510(k) number K171379.

Who is the listed applicant for Digital Automatic Wrist Blood Pressure Monitor MD4300?

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 Wrist Blood Pressure Monitor MD4300?

The FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300 is DXN.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K191593Digital Automatic Blood Pressure Monitor MD36 Series K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series K163679Digital Automatic Blood Pressure Monitor MD3600 K163113Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.