FDA 510(k)

恩塞維斯（2.1）

K 號：K240993 · 2024-09-27

申請人Ait Austrian Institute of Technology GmbH

決定日期2024-09-27

產品代碼OMB

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

encevis (2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Ait Austrian Institute of Technology GmbH. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K240993. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the encevis (2.1)?

encevis (2.1) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Ait Austrian Institute of Technology GmbH. The 510(k) number is K240993.

When did encevis (2.1) receive FDA 510(k) clearance?

encevis (2.1) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K240993.

Who is the listed applicant for encevis (2.1)?

The FDA 510(k) record lists Ait Austrian Institute of Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for encevis (2.1)?

The FDA product code for encevis (2.1) is OMB.

其他以 Ait Austrian Institute of Technology GmbH 為申請人之記錄

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K171720醫療設備名稱：encevis

相關器械（代碼：OMB）

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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