FDA 510(k)

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

K号: K223855 · 2023-06-06

决定日期2023-06-06

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

FEops HEARTguideTM, FEops HEARTguideTM ALPACA is the device name listed in this FDA 510(k) record. The listed applicant is Feops NV. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K223855. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

FEops HEARTguideTM, FEops HEARTguideTM ALPACA is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Feops NV. The 510(k) number is K223855.

When did FEops HEARTguideTM, FEops HEARTguideTM ALPACA receive FDA 510(k) clearance?

FEops HEARTguideTM, FEops HEARTguideTM ALPACA received FDA 510(k) clearance on 2023-06-06, under 510(k) number K223855.

Who is the listed applicant for FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

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

What is the FDA product code for FEops HEARTguideTM, FEops HEARTguideTM ALPACA?

The FDA product code for FEops HEARTguideTM, FEops HEARTguideTM ALPACA is QIH.

列明Feops NV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。

K250635FEops HEARTguide Simulation Application K214066FEops HEARTguide

官方来源

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