FDA 510(k)

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device

N.º K: K193292 · 2019-12-20

SolicitanteApplied Medical Resources Corp.

Fecha de decisión2019-12-20

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Voyant 5mm Fusion Device, 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 2019-12-20 under 510(k) number K193292. 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 5mm Fusion Device, Voyant Maryland Fusion Device?

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K193292.

When did Voyant 5mm Fusion Device, Voyant Maryland Fusion Device receive FDA 510(k) clearance?

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193292.

Who is the listed applicant for Voyant 5mm Fusion Device, 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 5mm Fusion Device, Voyant Maryland Fusion Device?

The FDA product code for Voyant 5mm Fusion Device, 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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