RX-1 睡眠
K 號：K253148 · 2026-06-22
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器材摘要
RX-1 Sleep is the device name listed in this FDA 510(k) record. The listed applicant is Vivaquant, Inc. Dba Rhythm Express. It received FDA 510(k) clearance on 2026-06-22 under 510(k) number K253148. 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 RX-1 Sleep?
RX-1 Sleep is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Vivaquant, Inc. Dba Rhythm Express. The 510(k) number is K253148.
When did RX-1 Sleep receive FDA 510(k) clearance?
RX-1 Sleep received FDA 510(k) clearance on 2026-06-22, under 510(k) number K253148.
Who is the listed applicant for RX-1 Sleep?
The FDA 510(k) record lists Vivaquant, Inc. Dba Rhythm Express as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RX-1 Sleep?
The FDA product code for RX-1 Sleep is MNR.
相關臨床試驗
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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。
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。
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