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FDA 510(k)

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K 號:K250153 · 2025-04-25

決定日期2025-04-25
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

Neu Platform is the device name listed in this FDA 510(k) record. The listed applicant is Neuhealth Digital , Ltd.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K250153. 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 Neu Platform?

Neu Platform is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Neuhealth Digital , Ltd.. The 510(k) number is K250153.

When did Neu Platform receive FDA 510(k) clearance?

Neu Platform received FDA 510(k) clearance on 2025-04-25, under 510(k) number K250153.

Who is the listed applicant for Neu Platform?

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

What is the FDA product code for Neu Platform?

The FDA product code for Neu Platform 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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