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FDA 510(k)

DELPHI 系統

K 號:K242907 · 2025-06-06

決定日期2025-06-06
產品代碼GEI
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

DELPHI System is the device name listed in this FDA 510(k) record. The listed applicant is CnS Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242907. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DELPHI System?

DELPHI System is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is CnS Medical Co., Ltd.. The 510(k) number is K242907.

When did DELPHI System receive FDA 510(k) clearance?

DELPHI System received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242907.

Who is the listed applicant for DELPHI System?

The FDA 510(k) record lists CnS Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELPHI System?

The FDA product code for DELPHI System is GEI.

相關臨床試驗

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相關器械(代碼:GEI)

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。

官方來源

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