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FDA 510(k)

ECG Check - Universal, ECG Check - Universal Plus

N.º K: K170506 · 2017-10-02

SolicitanteCardiac Designs, Inc.
Fecha de decisión2017-10-02
Código de productoDXH
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

ECG Check - Universal, ECG Check - Universal Plus is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Designs, Inc.. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K170506. 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 Check - Universal, ECG Check - Universal Plus?

ECG Check - Universal, ECG Check - Universal Plus is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Cardiac Designs, Inc.. The 510(k) number is K170506.

When did ECG Check - Universal, ECG Check - Universal Plus receive FDA 510(k) clearance?

ECG Check - Universal, ECG Check - Universal Plus received FDA 510(k) clearance on 2017-10-02, under 510(k) number K170506.

Who is the listed applicant for ECG Check - Universal, ECG Check - Universal Plus?

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

What is the FDA product code for ECG Check - Universal, ECG Check - Universal Plus?

The FDA product code for ECG Check - Universal, ECG Check - Universal Plus is DXH. This falls under the Hematology category.

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Fuente oficial

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