FDA 510(k)

StentBoost Mobile

K号: K203623 · 2021-04-05

决定日期2021-04-05

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Philips India Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K173187MobileDiagnost M50

官方来源

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