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)

BodyGuardian Remote Monitoring System (BGRMS v3.0)

N.º K: K243349 · 2026-01-23

SolicitanteBoston Scientific Cardiac Diagnostic Technologies, Inc.
Fecha de decisión2026-01-23
Código de productoDSI
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

BodyGuardian Remote Monitoring System (BGRMS v3.0) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Cardiac Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K243349. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BodyGuardian Remote Monitoring System (BGRMS v3.0)?

BodyGuardian Remote Monitoring System (BGRMS v3.0) is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Boston Scientific Cardiac Diagnostic Technologies, Inc.. The 510(k) number is K243349.

When did BodyGuardian Remote Monitoring System (BGRMS v3.0) receive FDA 510(k) clearance?

BodyGuardian Remote Monitoring System (BGRMS v3.0) received FDA 510(k) clearance on 2026-01-23, under 510(k) number K243349.

Who is the listed applicant for BodyGuardian Remote Monitoring System (BGRMS v3.0)?

The FDA 510(k) record lists Boston Scientific Cardiac Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BodyGuardian Remote Monitoring System (BGRMS v3.0)?

The FDA product code for BodyGuardian Remote Monitoring System (BGRMS v3.0) is DSI.

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: DSI)

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.

K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.K192732BodyGuardian Remote Monitoring SystemPreventice Technologies, 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.

↑