FDA 510(k)

VSP脉冲

K号: K214093 · 2022-03-30

决定日期2022-03-30

产品代码IXI

咨询委员会RA

决定实质等同

器械摘要

VSP Bolus is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems. It received FDA 510(k) clearance on 2022-03-30 under 510(k) number K214093. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VSP Bolus?

VSP Bolus is a medical device that received FDA 510(k) clearance on 2022-03-30. The listed applicant is 3D Systems. The 510(k) number is K214093.

When did VSP Bolus receive FDA 510(k) clearance?

VSP Bolus received FDA 510(k) clearance on 2022-03-30, under 510(k) number K214093.

Who is the listed applicant for VSP Bolus?

The FDA 510(k) record lists 3D Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSP Bolus?

The FDA product code for VSP Bolus is IXI.

列明3D Systems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。

K211244VSP® 骨科系统 K210347VSP系统 K193432Vantage PSI系统 K192192VSP系统

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。