Q13 SPIROLYSER®
K 號：K161676 · 2016-10-20
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器材摘要
Q13 SPIROLYSER® is the device name listed in this FDA 510(k) record. The listed applicant is Fim Medical. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K161676. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Q13 SPIROLYSER®?
Q13 SPIROLYSER® is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Fim Medical. The 510(k) number is K161676.
When did Q13 SPIROLYSER® receive FDA 510(k) clearance?
Q13 SPIROLYSER® received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161676.
Who is the listed applicant for Q13 SPIROLYSER®?
The FDA 510(k) record lists Fim Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Q13 SPIROLYSER®?
The FDA product code for Q13 SPIROLYSER® is BZG.
相關臨床試驗
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相關器械（代碼：BZG）
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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