FDA 510(k)

Infinix INFX-8000V, V6.40

K 號：K170909 · 2017-06-16

決定日期2017-06-16

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Infinix INFX-8000V, V6.40 is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba Medical Systems Coroporation. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K170909. 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 Infinix INFX-8000V, V6.40?

Infinix INFX-8000V, V6.40 is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Toshiba Medical Systems Coroporation. The 510(k) number is K170909.

When did Infinix INFX-8000V, V6.40 receive FDA 510(k) clearance?

Infinix INFX-8000V, V6.40 received FDA 510(k) clearance on 2017-06-16, under 510(k) number K170909.

Who is the listed applicant for Infinix INFX-8000V, V6.40?

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

What is the FDA product code for Infinix INFX-8000V, V6.40?

The FDA product code for Infinix INFX-8000V, V6.40 is OWB.

其他以 Toshiba Medical Systems Coroporation 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。

K172188Aquilion Prime SP, TSX-303B/1, v8.4

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。