FDA 510(k)

Arm-Type Fully Automatic Digital Blood Pressure Monitor

Número K: K161577 · 2017-02-08

RequerenteSejoy Electronics & Instruments Co., Ltd.

Data da decisão2017-02-08

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Arm-Type Fully Automatic Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K161577. 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 Arm-Type Fully Automatic Digital Blood Pressure Monitor?

Arm-Type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K161577.

When did Arm-Type Fully Automatic Digital Blood Pressure Monitor receive FDA 510(k) clearance?

Arm-Type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2017-02-08, under 510(k) number K161577.

Who is the listed applicant for Arm-Type Fully Automatic Digital Blood Pressure Monitor?

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

What is the FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor?

The FDA product code for Arm-Type Fully Automatic Digital Blood Pressure Monitor 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 Sejoy Electronics & Instruments Co., Ltd. como candidato(a)

K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 K153146Infrared Ear Thermometer

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.