FDA 510(k)

URUS系統（DMG-SU100/URUS）；URUS系統（DMG-SU100R/URUS）；URUS系統（VP-100/視頻處理器）

K 號：K240203 · 2024-09-05

決定日期2024-09-05

產品代碼FGB

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Dyne Medical Group, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252933DYNE PORT

相關器械（代碼：FGB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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