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FDA 510(k)

神經RPM

K 號:K221772 · 2023-03-17

決定日期2023-03-17
產品代碼GYD
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

NeuroRPM is the device name listed in this FDA 510(k) record. The listed applicant is New Touch Digital, Inc.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K221772. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeuroRPM?

NeuroRPM is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is New Touch Digital, Inc.. The 510(k) number is K221772.

When did NeuroRPM receive FDA 510(k) clearance?

NeuroRPM received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221772.

Who is the listed applicant for NeuroRPM?

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

What is the FDA product code for NeuroRPM?

The FDA product code for NeuroRPM is GYD.

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相關器械(代碼:GYD)

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。

官方來源

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