Oxevision 睡眠設備
K 號：K233618 · 2024-04-03
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器材摘要
Oxevision Sleep Device is the device name listed in this FDA 510(k) record. The listed applicant is Oxehealth Limited. It received FDA 510(k) clearance on 2024-04-03 under 510(k) number K233618. The device is classified under product code LEL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Oxevision Sleep Device?
Oxevision Sleep Device is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is Oxehealth Limited. The 510(k) number is K233618.
When did Oxevision Sleep Device receive FDA 510(k) clearance?
Oxevision Sleep Device received FDA 510(k) clearance on 2024-04-03, under 510(k) number K233618.
Who is the listed applicant for Oxevision Sleep Device?
The FDA 510(k) record lists Oxehealth Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oxevision Sleep Device?
The FDA product code for Oxevision Sleep Device is LEL.
相關臨床試驗
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其他以 Oxehealth 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。
相關器械（代碼：LEL）
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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