AirFit N20
K 號：K161978 · 2016-11-17
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器材摘要
AirFit N20 is the device name listed in this FDA 510(k) record. The listed applicant is Resmed, Ltd.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K161978. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AirFit N20?
AirFit N20 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Resmed, Ltd.. The 510(k) number is K161978.
When did AirFit N20 receive FDA 510(k) clearance?
AirFit N20 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K161978.
Who is the listed applicant for AirFit N20?
The FDA 510(k) record lists Resmed, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirFit N20?
The FDA product code for AirFit N20 is BZD.
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其他以 Resmed, Ltd. 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：BZD）
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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