Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Fully Automatic Electronic Blood Pressure Monitor

N.º K: K162230 · 2016-11-18

SolicitanteAdon Health Co., Ltd.
Fecha de decisión2016-11-18
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Fully Automatic Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Adon Health Co., Ltd.. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162230. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Fully Automatic Electronic Blood Pressure Monitor?

Fully Automatic Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Adon Health Co., Ltd.. The 510(k) number is K162230.

When did Fully Automatic Electronic Blood Pressure Monitor receive FDA 510(k) clearance?

Fully Automatic Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162230.

Who is the listed applicant for Fully Automatic Electronic Blood Pressure Monitor?

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

What is the FDA product code for Fully Automatic Electronic Blood Pressure Monitor?

The FDA product code for Fully Automatic Electronic Blood Pressure Monitor is DXN.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: DXN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑