FDA 510(k)

SKOUT® 系统

K号: K240781 · 2024-04-19

决定日期2024-04-19

产品代码QNP

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决定实质等同

器械摘要

SKOUT® system is the device name listed in this FDA 510(k) record. The listed applicant is Iterative Scopes, Inc.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K240781. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SKOUT® system?

SKOUT® system is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Iterative Scopes, Inc.. The 510(k) number is K240781.

When did SKOUT® system receive FDA 510(k) clearance?

SKOUT® system received FDA 510(k) clearance on 2024-04-19, under 510(k) number K240781.

Who is the listed applicant for SKOUT® system?

The FDA 510(k) record lists Iterative Scopes, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKOUT® system?

The FDA product code for SKOUT® system is QNP.

列明Iterative Scopes, Inc.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。

K241508SKOUT® 系统 K230658SKOUT® 系统 K213686SKOUT 软件

官方来源

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