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FDA 510(k)

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile

N.º K: K181310 · 2019-02-22

SolicitanteCardiocomm Solutions, Inc.
Fecha de decisión2019-02-22
Código de productoDXH
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocomm Solutions, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K181310. 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 HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Cardiocomm Solutions, Inc.. The 510(k) number is K181310.

When did HeartCheck Cardi Beat ECG Monitor with GEMS Mobile receive FDA 510(k) clearance?

HeartCheck Cardi Beat ECG Monitor with GEMS Mobile received FDA 510(k) clearance on 2019-02-22, under 510(k) number K181310.

Who is the listed applicant for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

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

What is the FDA product code for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile?

The FDA product code for HeartCheck Cardi Beat ECG Monitor with GEMS Mobile is DXH. This falls under the Hematology category.

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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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