FDA 510(k)

URUS系统（DMG-SU100/URUS）；URUS系统（DMG-SU100R/URUS）；URUS系统（VP-100/视频处理器）

K号: K240203 · 2024-09-05

决定日期2024-09-05

产品代码FGB

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决定实质等同

器械摘要

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.

常见问题

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.

列明Dyne Medical Group, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252933DYNE PORT

相关器械（代码：FGB）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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