FDA 510(k)

DEKA SIMON

K 號：K232334 · 2023-09-01

決定日期2023-09-01

產品代碼IPF

諮詢委員會PM

決定相當於

器材摘要

DEKA SIMON is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232334. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DEKA SIMON?

DEKA SIMON is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is El.En S.P.A.. The 510(k) number is K232334.

When did DEKA SIMON receive FDA 510(k) clearance?

DEKA SIMON received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232334.

Who is the listed applicant for DEKA SIMON?

The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA SIMON?

The FDA product code for DEKA SIMON is IPF.

其他以 El.En S.P.A. 為申請人之記錄

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相關器械（代碼：IPF）

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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