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FDA 510(k)

Carilex VT¿200-i NX

K号: K231646 · 2024-04-17

决定日期2024-04-17
产品代码OMP
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决定实质等同

器械摘要

Carilex VT¿200-i NX is the device name listed in this FDA 510(k) record. The listed applicant is Carilex Medical, Inc.. It received FDA 510(k) clearance on 2024-04-17 under 510(k) number K231646. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Carilex VT¿200-i NX?

Carilex VT¿200-i NX is a medical device that received FDA 510(k) clearance on 2024-04-17. The listed applicant is Carilex Medical, Inc.. The 510(k) number is K231646.

When did Carilex VT¿200-i NX receive FDA 510(k) clearance?

Carilex VT¿200-i NX received FDA 510(k) clearance on 2024-04-17, under 510(k) number K231646.

Who is the listed applicant for Carilex VT¿200-i NX?

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

What is the FDA product code for Carilex VT¿200-i NX?

The FDA product code for Carilex VT¿200-i NX is OMP.

相关临床试验

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。

列明Carilex Medical, 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。

相关器械(代码:OMP)

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。

官方来源

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