FDA 510(k)

Anjon Bremer Halo 系統

K 號：K193256 · 2020-03-02

決定日期2020-03-02

產品代碼JEC

諮詢委員會或

決定相當於

器材摘要

Anjon Bremer Halo System is the device name listed in this FDA 510(k) record. The listed applicant is Anjon Holdings, LLC. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K193256. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anjon Bremer Halo System?

Anjon Bremer Halo System is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is Anjon Holdings, LLC. The 510(k) number is K193256.

When did Anjon Bremer Halo System receive FDA 510(k) clearance?

Anjon Bremer Halo System received FDA 510(k) clearance on 2020-03-02, under 510(k) number K193256.

Who is the listed applicant for Anjon Bremer Halo System?

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

What is the FDA product code for Anjon Bremer Halo System?

The FDA product code for Anjon Bremer Halo System is JEC.

其他以 Anjon Holdings, LLC 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。

K171863Anjon Bremer Halo 系統

相關器械（代碼：JEC）

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。

K203605醫療設備註冊文本翻譯（zh-TW）： SteriTrakArbutus Medical, Inc.K192465DigiFix 無菌套件Virak Orthopedics, LLC K181192PIP修復Hand Biomechanics Lab, Inc.K171863Anjon Bremer Halo 系統Anjon Holdings, LLC K163028Medline ReNewal 再生處理 Stryker 外固定設備Surgical Instrument Service and Savings, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。