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)

CMS-2000 Central Monitoring System

N.º K: K172966 · 2017-12-08

SolicitanteAdvanced Instumentations, Inc.
Fecha de decisión2017-12-08
Código de productoMHX
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

CMS-2000 Central Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instumentations, Inc.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K172966. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CMS-2000 Central Monitoring System?

CMS-2000 Central Monitoring System is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Advanced Instumentations, Inc.. The 510(k) number is K172966.

When did CMS-2000 Central Monitoring System receive FDA 510(k) clearance?

CMS-2000 Central Monitoring System received FDA 510(k) clearance on 2017-12-08, under 510(k) number K172966.

Who is the listed applicant for CMS-2000 Central Monitoring System?

The FDA 510(k) record lists Advanced Instumentations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMS-2000 Central Monitoring System?

The FDA product code for CMS-2000 Central Monitoring System is MHX.

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: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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.

↑