FDA 510(k)

SignalNED 系統（型號 RE）

K 號：K242306 · 2024-09-04

決定日期2024-09-04

產品代碼OMC

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

SignalNED System (Model RE) is the device name listed in this FDA 510(k) record. The listed applicant is Forest Devices, Inc.. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K242306. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SignalNED System (Model RE)?

SignalNED System (Model RE) is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Forest Devices, Inc.. The 510(k) number is K242306.

When did SignalNED System (Model RE) receive FDA 510(k) clearance?

SignalNED System (Model RE) received FDA 510(k) clearance on 2024-09-04, under 510(k) number K242306.

Who is the listed applicant for SignalNED System (Model RE)?

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

What is the FDA product code for SignalNED System (Model RE)?

The FDA product code for SignalNED System (Model RE) is OMC.

其他以 Forest Devices, Inc. 為申請人之記錄

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K251726SignalNED 系統（型號 RE）

相關器械（代碼：OMC）

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。

K261101塞瑞貝爾監護器Ceribell, Inc.K251550NX01 (NX01)Naox Technologies Sas K251726SignalNED 系統（型號 RE）Forest Devices, Inc.K243185REMI遠端電腦電腦電極圖監測系統Epitel K242930Natus腦波監測系統Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, Ltd.

官方來源

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