FDA 510(k)

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

Número K: K240203 · 2024-09-05

Data da decisão2024-09-05

Código do produtoFGB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Dyne Medical Group, Inc. como candidato(a)

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