FDA 510(k)

Litho 60; Litho 100; Litho 150

K号: K242251 · 2024-09-03

决定日期2024-09-03

产品代码GEX

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决定实质等同

器械摘要

Litho 60; Litho 100; Litho 150 is the device name listed in this FDA 510(k) record. The listed applicant is Quanta System Spa. It received FDA 510(k) clearance on 2024-09-03 under 510(k) number K242251. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Litho 60; Litho 100; Litho 150?

Litho 60; Litho 100; Litho 150 is a medical device that received FDA 510(k) clearance on 2024-09-03. The listed applicant is Quanta System Spa. The 510(k) number is K242251.

When did Litho 60; Litho 100; Litho 150 receive FDA 510(k) clearance?

Litho 60; Litho 100; Litho 150 received FDA 510(k) clearance on 2024-09-03, under 510(k) number K242251.

Who is the listed applicant for Litho 60; Litho 100; Litho 150?

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

What is the FDA product code for Litho 60; Litho 100; Litho 150?

The FDA product code for Litho 60; Litho 100; Litho 150 is GEX. This falls under the Gastroenterology category.

列明Quanta System Spa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。

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官方来源

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