FDA 510(k)

Catalyst+，Catalyst+ HD

K号: K200435 · 2020-05-07

决定日期2020-05-07

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Catalyst+, Catalyst+ HD is the device name listed in this FDA 510(k) record. The listed applicant is C-Rad Positioning AB. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K200435. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Catalyst+, Catalyst+ HD?

Catalyst+, Catalyst+ HD is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is C-Rad Positioning AB. The 510(k) number is K200435.

When did Catalyst+, Catalyst+ HD receive FDA 510(k) clearance?

Catalyst+, Catalyst+ HD received FDA 510(k) clearance on 2020-05-07, under 510(k) number K200435.

Who is the listed applicant for Catalyst+, Catalyst+ HD?

The FDA 510(k) record lists C-Rad Positioning AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catalyst+, Catalyst+ HD?

The FDA product code for Catalyst+, Catalyst+ HD is IYE.

列明C-Rad Positioning AB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。

K200600Sentinel

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