FDA 510(k)

創世睡眠

K 號：K252951 · 2025-12-31

決定日期2025-12-31

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

Genesis Sleep is the device name listed in this FDA 510(k) record. The listed applicant is Neurofield, Inc.. It received FDA 510(k) clearance on 2025-12-31 under 510(k) number K252951. 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 Genesis Sleep?

Genesis Sleep is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Neurofield, Inc.. The 510(k) number is K252951.

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

Genesis Sleep received FDA 510(k) clearance on 2025-12-31, under 510(k) number K252951.

Who is the listed applicant for Genesis Sleep?

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

What is the FDA product code for Genesis Sleep?

The FDA product code for Genesis Sleep is QJQ.

其他以 Neurofield, Inc. 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。

K240420神經領域分析套件 K221959Q21 Q21 (請提供完整的原文，以便進行翻譯。)

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。

K232253Modius 压力Neurovalens Limited K230826Modius 睡眠Neurovalens , Ltd.K182311CervellaInnovative Neurological Devices, LLC

官方來源

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