FDA 510(k)

Infrascanner 型号 2500 (型号 2500)

K号: K241389 · 2024-12-12

决定日期2024-12-12

产品代码OPT

咨询委员会OP 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Infrascanner Model 2500 (Model 2500) is the device name listed in this FDA 510(k) record. The listed applicant is Infrascan, Inc.. It received FDA 510(k) clearance on 2024-12-12 under 510(k) number K241389. The device is classified under product code OPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Infrascanner Model 2500 (Model 2500)?

Infrascanner Model 2500 (Model 2500) is a medical device that received FDA 510(k) clearance on 2024-12-12. The listed applicant is Infrascan, Inc.. The 510(k) number is K241389.

When did Infrascanner Model 2500 (Model 2500) receive FDA 510(k) clearance?

Infrascanner Model 2500 (Model 2500) received FDA 510(k) clearance on 2024-12-12, under 510(k) number K241389.

Who is the listed applicant for Infrascanner Model 2500 (Model 2500)?

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

What is the FDA product code for Infrascanner Model 2500 (Model 2500)?

The FDA product code for Infrascanner Model 2500 (Model 2500) is OPT.

列明Infrascan, 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。

K211617Infrascanner K200203Infrascanner

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。