FDA 510(k)

iTOF®

K 號：K242525 · 2024-12-05

申請人Nerbio Medical Software Platforms, Inc.

決定日期2024-12-05

產品代碼KOI

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：KOI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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