FDA 510(k)

SQ.line 賽里遜

K 號：K223596 · 2023-06-29

決定日期2023-06-29

產品代碼HAE

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

SQ.line KERRISON is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2023-06-29 under 510(k) number K223596. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SQ.line KERRISON?

SQ.line KERRISON is a medical device that received FDA 510(k) clearance on 2023-06-29. The listed applicant is Aesculap, Inc.. The 510(k) number is K223596.

When did SQ.line KERRISON receive FDA 510(k) clearance?

SQ.line KERRISON received FDA 510(k) clearance on 2023-06-29, under 510(k) number K223596.

Who is the listed applicant for SQ.line KERRISON?

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 SQ.line KERRISON?

The FDA product code for SQ.line KERRISON is HAE.

其他以 Aesculap, Inc. 為申請人之記錄

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相關器械（代碼：HAE）

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。

K260446Tontarra 打擊器與磨削器Tontarra Medizintechnik GmbH K242759Geister K-Rex 適應性咬合器Geister Medizin Technik GmbH K230256叛亂，幻影多咬合凱遜鋸齒刀Morpheus AG K221818叛亂；幻影多咬式凱遜咬骨器Morpheus AG K210741KLS Martin 神經鍵盤KLS-Martin L.P.K200768叛亂，幻影多咬合凱遜鋸齒刀Morpheus AG

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