FDA 510(k)

Artemis, Artemis TPO, Artemis MX

K 號：K222222 · 2023-10-12

申請人Eigen

決定日期2023-10-12

產品代碼QTZ

諮詢委員會RA

決定相當於

器材摘要

Artemis, Artemis TPO, Artemis MX is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K222222. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Artemis, Artemis TPO, Artemis MX?

Artemis, Artemis TPO, Artemis MX is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Eigen. The 510(k) number is K222222.

When did Artemis, Artemis TPO, Artemis MX receive FDA 510(k) clearance?

Artemis, Artemis TPO, Artemis MX received FDA 510(k) clearance on 2023-10-12, under 510(k) number K222222.

Who is the listed applicant for Artemis, Artemis TPO, Artemis MX?

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

What is the FDA product code for Artemis, Artemis TPO, Artemis MX?

The FDA product code for Artemis, Artemis TPO, Artemis MX is QTZ.

其他以 Eigen 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。

K173744ProFuse CAD K162474Artemis

相關器械（代碼：QTZ）

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。

K253264我的消融導引器（VC10A）Siemens Healthcare GmbH K252947HistoSonics®規劃工具HistoSonics, Inc.K251931BioTraceIO 頻道視覺 (V1.7)Techsomed Medical Technologies K240796myAblation導引器（VB80A）Siemens Healthcare GmbH K240773VisAble.IOTechsomed K222938Ablation-fitR.A.W. S.R.L

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。