FDA 510(k)

Noxturnal 網絡

K 號：K260585 · 2026-03-20

決定日期2026-03-20

產品代碼OLV

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

Noxturnal Web is the device name listed in this FDA 510(k) record. The listed applicant is Nox Medical Ehf. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K260585. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Noxturnal Web?

Noxturnal Web is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Nox Medical Ehf. The 510(k) number is K260585.

When did Noxturnal Web receive FDA 510(k) clearance?

Noxturnal Web received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260585.

Who is the listed applicant for Noxturnal Web?

The FDA 510(k) record lists Nox Medical Ehf as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Noxturnal Web?

The FDA product code for Noxturnal Web is OLV.

其他以 Nox Medical Ehf 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。

K252330深呼吸設備 K241960深呼吸設備 K241288Noxturnal 網絡

相關器械（代碼：OLV）

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。

K261747報告工作室Beacon Biosignals, Inc.K242447Falcon HSTCompumedics Limited K241288Noxturnal 網絡Nox Medical Ehf K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH K213007Cerebra 睡眠系統Cerebra Medical , Ltd.K201054SOMNOscreen plusSomnomedics GmbH

官方來源

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