FDA 510(k)

iTOF®

K号: K242525 · 2024-12-05

申请人Nerbio Medical Software Platforms, Inc.

决定日期2024-12-05

产品代码KOI

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决定实质等同

器械摘要

iTOF® is the device name listed in this FDA 510(k) record. The listed applicant is Nerbio Medical Software Platforms, Inc.. It received FDA 510(k) clearance on 2024-12-05 under 510(k) number K242525. The device is classified under product code KOI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iTOF®?

iTOF® is a medical device that received FDA 510(k) clearance on 2024-12-05. The listed applicant is Nerbio Medical Software Platforms, Inc.. The 510(k) number is K242525.

When did iTOF® receive FDA 510(k) clearance?

iTOF® received FDA 510(k) clearance on 2024-12-05, under 510(k) number K242525.

Who is the listed applicant for iTOF®?

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

What is the FDA product code for iTOF®?

The FDA product code for iTOF® is KOI.

相关器械（代码：KOI）

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。

K261098TetraGraph神经肌肉传导监测器（SEN 2015）配件：TetraSens（SEN 2012）TetraSens儿童（SEN 2013）TetraSensitive（SEN 2016）TetraHub（SEN 2017）Senzime AB K250887神经肌肉传导监测器TOF3D (2510091)MIPM Mammendorfer Institut für Physik und Medizin GmbH K243339WiTOFIdmed K220530Tetragraph神经肌肉传导监测器Senzime AB K220976Life Scope PT BSM-1700系列床旁监护仪Nihon Kohden Corporation K212434神经肌肉传导监测器TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbH

官方来源

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