AirPhysio正呼氣壓力(PEP)設備
K 號：K203209 · 2021-01-15
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器材摘要
AirPhysio Positive Expiratory Pressure (PEP) Device is the device name listed in this FDA 510(k) record. The listed applicant is Airphysio Pty, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203209. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AirPhysio Positive Expiratory Pressure (PEP) Device?
AirPhysio Positive Expiratory Pressure (PEP) Device is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Airphysio Pty, Ltd.. The 510(k) number is K203209.
When did AirPhysio Positive Expiratory Pressure (PEP) Device receive FDA 510(k) clearance?
AirPhysio Positive Expiratory Pressure (PEP) Device received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203209.
Who is the listed applicant for AirPhysio Positive Expiratory Pressure (PEP) Device?
The FDA 510(k) record lists Airphysio Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device?
The FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device is BYI.
相關臨床試驗
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相關器械（代碼：BYI）
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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