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)

ABPM 7100, Software de Gestión de Hipertensión

N.º K: K153557 · 2016-07-19

SolicitanteI.E.M. GmbH
Fecha de decisión2016-07-19
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

ABPM 7100, Hypertension Management Software is the device name listed in this FDA 510(k) record. The listed applicant is I.E.M. GmbH. It received FDA 510(k) clearance on 2016-07-19 under 510(k) number K153557. 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 ABPM 7100, Hypertension Management Software?

ABPM 7100, Hypertension Management Software is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is I.E.M. GmbH. The 510(k) number is K153557.

When did ABPM 7100, Hypertension Management Software receive FDA 510(k) clearance?

ABPM 7100, Hypertension Management Software received FDA 510(k) clearance on 2016-07-19, under 510(k) number K153557.

Who is the listed applicant for ABPM 7100, Hypertension Management Software?

The FDA 510(k) record lists I.E.M. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABPM 7100, Hypertension Management Software?

The FDA product code for ABPM 7100, Hypertension Management Software 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.

↑