FDA 510(k)

神經-IOM系統搭配神經-IOM.NET軟體

K 號：K190703 · 2021-05-22

決定日期2021-05-22

產品代碼GWF

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Neuro-IOM system with Neuro-IOM.NET software is the device name listed in this FDA 510(k) record. The listed applicant is Neurosoft , Ltd.. It received FDA 510(k) clearance on 2021-05-22 under 510(k) number K190703. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neuro-IOM system with Neuro-IOM.NET software?

Neuro-IOM system with Neuro-IOM.NET software is a medical device that received FDA 510(k) clearance on 2021-05-22. The listed applicant is Neurosoft , Ltd.. The 510(k) number is K190703.

When did Neuro-IOM system with Neuro-IOM.NET software receive FDA 510(k) clearance?

Neuro-IOM system with Neuro-IOM.NET software received FDA 510(k) clearance on 2021-05-22, under 510(k) number K190703.

Who is the listed applicant for Neuro-IOM system with Neuro-IOM.NET software?

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

What is the FDA product code for Neuro-IOM system with Neuro-IOM.NET software?

The FDA product code for Neuro-IOM system with Neuro-IOM.NET software is GWF.

其他以 Neurosoft , Ltd. 為申請人之記錄

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。

K220254神經頻譜-AM 配套 Neuron-Spectrum.NET 軟體

相關器械（代碼：GWF）

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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