我的LED口罩
K 號：K223147 · 2023-05-14
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器材摘要
myLEDmask is the device name listed in this FDA 510(k) record. The listed applicant is Myblend. It received FDA 510(k) clearance on 2023-05-14 under 510(k) number K223147. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the myLEDmask?
myLEDmask is a medical device that received FDA 510(k) clearance on 2023-05-14. The listed applicant is Myblend. The 510(k) number is K223147.
When did myLEDmask receive FDA 510(k) clearance?
myLEDmask received FDA 510(k) clearance on 2023-05-14, under 510(k) number K223147.
Who is the listed applicant for myLEDmask?
The FDA 510(k) record lists Myblend as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for myLEDmask?
The FDA product code for myLEDmask is OHS.
相關臨床試驗
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相關器械（代碼：OHS）
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。
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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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