FDA 510(k)

ACTIVBRAID™

K 號：K223822 · 2023-06-02

決定日期2023-06-02

產品代碼GAT

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

ACTIVBRAID™ is the device name listed in this FDA 510(k) record. The listed applicant is Embody, Inc.. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K223822. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACTIVBRAID™?

ACTIVBRAID™ is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Embody, Inc.. The 510(k) number is K223822.

When did ACTIVBRAID™ receive FDA 510(k) clearance?

ACTIVBRAID™ received FDA 510(k) clearance on 2023-06-02, under 510(k) number K223822.

Who is the listed applicant for ACTIVBRAID™?

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

What is the FDA product code for ACTIVBRAID™?

The FDA product code for ACTIVBRAID™ is GAT.

其他以 Embody, Inc. 為申請人之記錄

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相關器械（代碼：GAT）

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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