FDA 510(k)

HomeSleepTest (HST, HST REM+)

K 號：K240700 · 2024-12-08

決定日期2024-12-08

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

HomeSleepTest (HST, HST REM+) is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2024-12-08 under 510(k) number K240700. 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 HomeSleepTest (HST, HST REM+)?

HomeSleepTest (HST, HST REM+) is a medical device that received FDA 510(k) clearance on 2024-12-08. The listed applicant is Somnomedics GmbH. The 510(k) number is K240700.

When did HomeSleepTest (HST, HST REM+) receive FDA 510(k) clearance?

HomeSleepTest (HST, HST REM+) received FDA 510(k) clearance on 2024-12-08, under 510(k) number K240700.

Who is the listed applicant for HomeSleepTest (HST, HST REM+)?

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

What is the FDA product code for HomeSleepTest (HST, HST REM+)?

The FDA product code for HomeSleepTest (HST, HST REM+) is OLV.

其他以 Somnomedics GmbH 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。

K231104ABPMpro K212325電腦化電腦皮層電位檢查設備 K201054SOMNOscreen plus

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。

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官方來源

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