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FDA 510(k)

智滴

K 號:K251598 · 2025-12-10

決定日期2025-12-10
產品代碼JXG
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

Intellidrop is the device name listed in this FDA 510(k) record. The listed applicant is Brainspace, Inc.. It received FDA 510(k) clearance on 2025-12-10 under 510(k) number K251598. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intellidrop?

Intellidrop is a medical device that received FDA 510(k) clearance on 2025-12-10. The listed applicant is Brainspace, Inc.. The 510(k) number is K251598.

When did Intellidrop receive FDA 510(k) clearance?

Intellidrop received FDA 510(k) clearance on 2025-12-10, under 510(k) number K251598.

Who is the listed applicant for Intellidrop?

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

What is the FDA product code for Intellidrop?

The FDA product code for Intellidrop is JXG.

相關臨床試驗

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相關器械(代碼:JXG)

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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