AeroForm 絇組擴張器，光滑
K 號：K191138 · 2019-07-11
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器材摘要
AeroForm Tissue Expander, Smooth is the device name listed in this FDA 510(k) record. The listed applicant is Airxpanders, Inc.. It received FDA 510(k) clearance on 2019-07-11 under 510(k) number K191138. The device is classified under product code PQN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AeroForm Tissue Expander, Smooth?
AeroForm Tissue Expander, Smooth is a medical device that received FDA 510(k) clearance on 2019-07-11. The listed applicant is Airxpanders, Inc.. The 510(k) number is K191138.
When did AeroForm Tissue Expander, Smooth receive FDA 510(k) clearance?
AeroForm Tissue Expander, Smooth received FDA 510(k) clearance on 2019-07-11, under 510(k) number K191138.
Who is the listed applicant for AeroForm Tissue Expander, Smooth?
The FDA 510(k) record lists Airxpanders, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AeroForm Tissue Expander, Smooth?
The FDA product code for AeroForm Tissue Expander, Smooth is PQN.
相關臨床試驗
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其他以 Airxpanders, Inc. 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：PQN）
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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