FDA 510(k)

Voyant Maryland Fusion Device

N.º K: K182653 · 2018-11-14

SolicitanteApplied Medical Resources Corp.

Fecha de decisión2018-11-14

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Voyant Maryland Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K182653. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Voyant Maryland Fusion Device?

Voyant Maryland Fusion Device is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K182653.

When did Voyant Maryland Fusion Device receive FDA 510(k) clearance?

Voyant Maryland Fusion Device received FDA 510(k) clearance on 2018-11-14, under 510(k) number K182653.

Who is the listed applicant for Voyant Maryland Fusion Device?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant Maryland Fusion Device?

The FDA product code for Voyant Maryland Fusion Device is GEI.

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Otros registros que enlistan a Applied Medical Resources Corp. como solicitante

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Fuente oficial

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