FDA 510(k)

StentBoost 行動裝置

K 號：K203623 · 2021-04-05

決定日期2021-04-05

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

StentBoost Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Philips India Limited. It received FDA 510(k) clearance on 2021-04-05 under 510(k) number K203623. 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 StentBoost Mobile?

StentBoost Mobile is a medical device that received FDA 510(k) clearance on 2021-04-05. The listed applicant is Philips India Limited. The 510(k) number is K203623.

When did StentBoost Mobile receive FDA 510(k) clearance?

StentBoost Mobile received FDA 510(k) clearance on 2021-04-05, under 510(k) number K203623.

Who is the listed applicant for StentBoost Mobile?

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

What is the FDA product code for StentBoost Mobile?

The FDA product code for StentBoost Mobile is OWB.

其他以 Philips India Limited 為申請人之記錄

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K173187MobileDiagnost M50

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

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