FDA 510(k)

URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)

N.º K: K240203 · 2024-09-05

Fecha de decisión2024-09-05

Código de productoFGB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) is the device name listed in this FDA 510(k) record. The listed applicant is Dyne Medical Group, Inc.. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K240203. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)?

URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Dyne Medical Group, Inc.. The 510(k) number is K240203.

When did URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) receive FDA 510(k) clearance?

URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) received FDA 510(k) clearance on 2024-09-05, under 510(k) number K240203.

Who is the listed applicant for URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)?

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

What is the FDA product code for URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)?

The FDA product code for URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) is FGB.

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Otros registros que enlistan a Dyne Medical Group, Inc. como solicitante

K252933DYNE PORT

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Fuente oficial

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