FDA 510(k)

Geister K-Rex 適應性咬合器

K 號：K242759 · 2025-06-06

決定日期2025-06-06

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

Geister K-Rex rongeurs is the device name listed in this FDA 510(k) record. The listed applicant is Geister Medizin Technik GmbH. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242759. 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 Geister K-Rex rongeurs?

Geister K-Rex rongeurs is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Geister Medizin Technik GmbH. The 510(k) number is K242759.

When did Geister K-Rex rongeurs receive FDA 510(k) clearance?

Geister K-Rex rongeurs received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242759.

Who is the listed applicant for Geister K-Rex rongeurs?

The FDA 510(k) record lists Geister Medizin Technik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Geister K-Rex rongeurs?

The FDA product code for Geister K-Rex rongeurs is HAE.

其他以 Geister Medizin Technik GmbH 為申請人之記錄

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K180610神經及脊椎手術用Geister拉钩

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 K223596SQ.line 賽里遜Aesculap, Inc.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

官方來源

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