FDA 510(k)

和聲OCT系統

K 號：K233366 · 2023-11-09

決定日期2023-11-09

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

SYMPHONY OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K233366. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SYMPHONY OCT System?

SYMPHONY OCT System is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Medos International SARL. The 510(k) number is K233366.

When did SYMPHONY OCT System receive FDA 510(k) clearance?

SYMPHONY OCT System received FDA 510(k) clearance on 2023-11-09, under 510(k) number K233366.

Who is the listed applicant for SYMPHONY OCT System?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYMPHONY OCT System?

The FDA product code for SYMPHONY OCT System is NKG.

其他以 Medos International SARL 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。

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相關器械（代碼：NKG）

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。

K254260VEGA 子宮頸螺釘系統GS Medical Co., Ltd.K253195泰魯斯後枕顱頸胸脊椎系統ZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® 頸椎後路螺釘系統；CarboClear® 混合後路螺釘系統CarboFix Orthopedics , Ltd.K254165Infinity™ 光學斷層掃描系統Medtronic Sofamor Danek USA, Inc.K252327CMORE® CT系統；CMORE® CT系統導航儀器Icotec AG K253129Infinity™ 光學斷層掃描系統Medtronic Sofamor Danek USA, Inc.

官方來源

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