FDA 510(k)

myAblation導引器（VB80A）

K 號：K240796 · 2024-08-06

決定日期2024-08-06

產品代碼QTZ

諮詢委員會RA

決定相當於

器材摘要

myAblation Guide (VB80A) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2024-08-06 under 510(k) number K240796. 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 myAblation Guide (VB80A)?

myAblation Guide (VB80A) is a medical device that received FDA 510(k) clearance on 2024-08-06. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K240796.

When did myAblation Guide (VB80A) receive FDA 510(k) clearance?

myAblation Guide (VB80A) received FDA 510(k) clearance on 2024-08-06, under 510(k) number K240796.

Who is the listed applicant for myAblation Guide (VB80A)?

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

What is the FDA product code for myAblation Guide (VB80A)?

The FDA product code for myAblation Guide (VB80A) is QTZ.

其他以 Siemens Healthcare GmbH 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。

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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 K240773VisAble.IOTechsomed K222222Artemis, Artemis TPO, Artemis MXEigen K222938Ablation-fitR.A.W. S.R.L

官方來源

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