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FDA 510(k)

ECG SENTINEL System

N.º K: K172801 · 2017-10-18

SolicitanteCardiomedix, Inc.
Fecha de decisión2017-10-18
Código de productoDXH
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

ECG SENTINEL System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiomedix, Inc.. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172801. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ECG SENTINEL System?

ECG SENTINEL System is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Cardiomedix, Inc.. The 510(k) number is K172801.

When did ECG SENTINEL System receive FDA 510(k) clearance?

ECG SENTINEL System received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172801.

Who is the listed applicant for ECG SENTINEL System?

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

What is the FDA product code for ECG SENTINEL System?

The FDA product code for ECG SENTINEL System is DXH. This falls under the Hematology category.

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Dispositivos relacionados (Código: DXH)

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.

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Fuente oficial

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

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