FDA 510(k)

Withings 睡眠藥物

K 號：K231667 · 2024-09-06

決定日期2024-09-06

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

Withings Sleep Rx is the device name listed in this FDA 510(k) record. The listed applicant is Withings. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K231667. 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 Withings Sleep Rx?

Withings Sleep Rx is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Withings. The 510(k) number is K231667.

When did Withings Sleep Rx receive FDA 510(k) clearance?

Withings Sleep Rx received FDA 510(k) clearance on 2024-09-06, under 510(k) number K231667.

Who is the listed applicant for Withings Sleep Rx?

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

What is the FDA product code for Withings Sleep Rx?

The FDA product code for Withings Sleep Rx is MNR.

其他以 Withings 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。

K252474Withings BeamO (SCT02)K240795Withings 心電圖應用程式 K230812Withings Scan Monitor 2.0 K160544Withings Thermo（型號SCT01）

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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