FDA 510(k)

齊姆視覺FD

K 號：K193230 · 2019-12-20

決定日期2019-12-20

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Ziehm Vision FD is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm Imaging GmbH. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193230. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ziehm Vision FD?

Ziehm Vision FD is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Ziehm Imaging GmbH. The 510(k) number is K193230.

When did Ziehm Vision FD receive FDA 510(k) clearance?

Ziehm Vision FD received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193230.

Who is the listed applicant for Ziehm Vision FD?

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

What is the FDA product code for Ziehm Vision FD?

The FDA product code for Ziehm Vision FD is OWB.

其他以 Ziehm Imaging 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。

K243646齊姆單人FD K243735齊姆視覺FD K243303齊姆視覺RFD 3D K243328齊姆視覺RFD K240099齊姆視覺RFD K240020齊姆視覺FD

查看所有 16 項裝置 →

相關器械（代碼：OWB）

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。

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH Corporation K254205Zenition 30Philips Medical Systems Nederland B.V.K260607防護系統（西門子 30x40）Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, 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。