FDA 510(k)

快樂健康家庭睡眠測試

K 號：K242224 · 2025-06-18

決定日期2025-06-18

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

Happy Health Home Sleep Test is the device name listed in this FDA 510(k) record. The listed applicant is Happy Health, Inc.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K242224. 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 Happy Health Home Sleep Test?

Happy Health Home Sleep Test is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Happy Health, Inc.. The 510(k) number is K242224.

When did Happy Health Home Sleep Test receive FDA 510(k) clearance?

Happy Health Home Sleep Test received FDA 510(k) clearance on 2025-06-18, under 510(k) number K242224.

Who is the listed applicant for Happy Health Home Sleep Test?

FDA 510(k) 記錄將 Happy Health, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Happy Health Home Sleep Test?

The FDA product code for Happy Health Home Sleep Test is MNR.

其他以 Happy Health, Inc. 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。

K254000快樂健康血壓監測器 K240236快樂環健康監測系統

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。