FDA 510(k)

AcQGuide Flex con AcQCross QX, AcQGuide Mini con AcQCross QX

N.º K: K193509 · 2020-01-17

Fecha de decisión2020-01-17

Código de productoDYB

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K193509. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX?

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K193509.

When did AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX receive FDA 510(k) clearance?

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX received FDA 510(k) clearance on 2020-01-17, under 510(k) number K193509.

Who is the listed applicant for AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX?

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

What is the FDA product code for AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX?

The FDA product code for AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX is DYB.

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Fuente oficial

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