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FDA 510(k)

Modius 睡眠

K 號：K230826 · 2023-10-27

申請人Neurovalens , Ltd.
決定日期2023-10-27
產品代碼QJQ
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

Modius Sleep is the device name listed in this FDA 510(k) record. The listed applicant is Neurovalens , Ltd.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K230826. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Modius Sleep?

Modius Sleep is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Neurovalens , Ltd.. The 510(k) number is K230826.

When did Modius Sleep receive FDA 510(k) clearance?

Modius Sleep received FDA 510(k) clearance on 2023-10-27, under 510(k) number K230826.

Who is the listed applicant for Modius Sleep?

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

What is the FDA product code for Modius Sleep?

The FDA product code for Modius Sleep is QJQ.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QJQ）

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。

K252951創世睡眠Neurofield, Inc.K232253Modius 压力Neurovalens LimitedK182311CervellaInnovative Neurological Devices, LLC

官方來源

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