O2asis 個人氧氣濕化器
K 號：K193411 · 2020-11-12
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器材摘要
O2asis Personal Oxygen Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Perma Pure, LLC. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K193411. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the O2asis Personal Oxygen Humidifier?
O2asis Personal Oxygen Humidifier is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Perma Pure, LLC. The 510(k) number is K193411.
When did O2asis Personal Oxygen Humidifier receive FDA 510(k) clearance?
O2asis Personal Oxygen Humidifier received FDA 510(k) clearance on 2020-11-12, under 510(k) number K193411.
Who is the listed applicant for O2asis Personal Oxygen Humidifier?
The FDA 510(k) record lists Perma Pure, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for O2asis Personal Oxygen Humidifier?
The FDA product code for O2asis Personal Oxygen Humidifier is BTT.
相關臨床試驗
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相關器械（代碼：BTT）
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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