FDA 510(k)

Somfit D

K 號：K252383 · 2025-08-28

決定日期2025-08-28

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

Somfit D is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Limited. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K252383. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Somfit D?

Somfit D is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Compumedics Limited. The 510(k) number is K252383.

When did Somfit D receive FDA 510(k) clearance?

Somfit D received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252383.

Who is the listed applicant for Somfit D?

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 Somfit D?

The FDA product code for Somfit D is MNR.

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。

K242447Falcon HST K231546Somfit K230073Okti K191785歐里恩生命週期 MEG

相關器械（代碼：MNR）

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。

K260949一次性睡眠監測帶（CNSAC）CNSAC Medshop GmbH K254042觀察者PAT SWItamar Medical , Ltd.K260050WRAP系統Huneo, LLC K253148RX-1 睡眠Vivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

官方來源

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