FDA 510(k)

自成型磁鐵（Flexagon Plus OTOLoc）

K 號：K250541 · 2025-08-01

決定日期2025-08-01

產品代碼SAH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Self-Forming Magnet (Flexagon Plus OTOLoc) is the device name listed in this FDA 510(k) record. The listed applicant is GI Windows, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250541. The device is classified under product code SAH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Self-Forming Magnet (Flexagon Plus OTOLoc)?

Self-Forming Magnet (Flexagon Plus OTOLoc) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is GI Windows, Inc.. The 510(k) number is K250541.

When did Self-Forming Magnet (Flexagon Plus OTOLoc) receive FDA 510(k) clearance?

Self-Forming Magnet (Flexagon Plus OTOLoc) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250541.

Who is the listed applicant for Self-Forming Magnet (Flexagon Plus OTOLoc)?

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

What is the FDA product code for Self-Forming Magnet (Flexagon Plus OTOLoc)?

The FDA product code for Self-Forming Magnet (Flexagon Plus OTOLoc) is SAH.

其他以 GI Windows, Inc. 為申請人之記錄

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。

K253550自成型磁鐵（Flexagon Plus OTOLoc）K243482自成型磁鐵（Flexagon）K243213自形成磁鐵（FLEX SFM）

相關器械（代碼：SAH）

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。

K261467GT代謝磁鐵系統（MAG-04，DS-01）GT代謝磁鐵系統（MAG-05，DS-01）Gt Metabolic Solutions, Inc.K253102GT代謝磁力DI系統（MAG-01、MAG-02、DS-01）Gt Metabolic Solutions, Inc.K253550自成型磁鐵（Flexagon Plus OTOLoc）GI Windows, Inc.K243482自成型磁鐵（Flexagon）GI Windows, Inc.K243359MagDI系統（MAG-02，DS-01）Gt Metabolic Solutions, Inc.K243213自形成磁鐵（FLEX SFM）GI Windows, Inc.

官方來源

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