FDA 510(k)

ImPACT版本4

K号: K231688 · 2023-09-16

决定日期2023-09-16

产品代码POM

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

ImPACT Version 4 is the device name listed in this FDA 510(k) record. The listed applicant is Impact Applications, Inc.. It received FDA 510(k) clearance on 2023-09-16 under 510(k) number K231688. The device is classified under product code POM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ImPACT Version 4?

ImPACT Version 4 is a medical device that received FDA 510(k) clearance on 2023-09-16. The listed applicant is Impact Applications, Inc.. The 510(k) number is K231688.

When did ImPACT Version 4 receive FDA 510(k) clearance?

ImPACT Version 4 received FDA 510(k) clearance on 2023-09-16, under 510(k) number K231688.

Who is the listed applicant for ImPACT Version 4?

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

What is the FDA product code for ImPACT Version 4?

The FDA product code for ImPACT Version 4 is POM.

列明Impact Applications, 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。

K202485ImPACT版本4 K181223ImPACT K170551ImPACT快速测试 K170209ImPACT

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。