FDA 510(k)

Quicktome 软件套件

K号: K222359 · 2023-05-30

申请人Omniscient Neurotechnology Pty Ltd (O8t)

决定日期2023-05-30

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Quicktome Software Suite is the device name listed in this FDA 510(k) record. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K222359. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

什么是Quicktome软件套件？

Quicktome Software Suite is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). The 510(k) number is K222359.

Quicktome软件套件何时获得FDA 510(k)批准？

Quicktome Software Suite received FDA 510(k) clearance on 2023-05-30, under 510(k) number K222359.

Quicktome软件套件列出的申请人是谁？

The FDA 510(k) record lists Omniscient Neurotechnology Pty Ltd (O8t) as the applicant. This does not by itself establish the device manufacturer.

什么是Quicktome软件套件的FDA产品代码？

The FDA product code for Quicktome Software Suite is LLZ.

列明Omniscient Neurotechnology Pty Ltd (O8t)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。

K203518Quicktome

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。