FDA 510(k)

DIR 800

K 號：K202391 · 2021-01-21

決定日期2021-01-21

產品代碼IZI

諮詢委員會RA

決定相當於

器材摘要

DIR 800 is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2021-01-21 under 510(k) number K202391. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DIR 800?

DIR 800 is a medical device that received FDA 510(k) clearance on 2021-01-21. The listed applicant is Aesculap, Inc.. The 510(k) number is K202391.

When did DIR 800 receive FDA 510(k) clearance?

DIR 800 received FDA 510(k) clearance on 2021-01-21, under 510(k) number K202391.

Who is the listed applicant for DIR 800?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIR 800?

The FDA product code for DIR 800 is IZI.

其他以 Aesculap, Inc. 為申請人之記錄

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相關器械（代碼：IZI）

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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