FDA 510(k)

Falcon HST

K 號：K242447 · 2025-02-20

決定日期2025-02-20

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

Falcon HST is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Limited. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K242447. 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 Falcon HST?

Falcon HST is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Compumedics Limited. The 510(k) number is K242447.

When did Falcon HST receive FDA 510(k) clearance?

Falcon HST received FDA 510(k) clearance on 2025-02-20, under 510(k) number K242447.

Who is the listed applicant for Falcon HST?

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

What is the FDA product code for Falcon HST?

The FDA product code for Falcon HST is OLV.

其他以 Compumedics Limited 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。

K252383Somfit D K231546Somfit K230073Okti K191785歐里恩生命週期 MEG

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.K260585Noxturnal 網絡Nox Medical Ehf 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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