探索者空氣II
K 號：K214097 · 2022-02-25
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器材摘要
Explorer Air II is the device name listed in this FDA 510(k) record. The listed applicant is Surgvision GmbH. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K214097. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Explorer Air II?
Explorer Air II is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Surgvision GmbH. The 510(k) number is K214097.
When did Explorer Air II receive FDA 510(k) clearance?
Explorer Air II received FDA 510(k) clearance on 2022-02-25, under 510(k) number K214097.
Who is the listed applicant for Explorer Air II?
The FDA 510(k) record lists Surgvision GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Explorer Air II?
The FDA product code for Explorer Air II is IZI.
相關臨床試驗
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。
其他以 Surgvision GmbH 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：IZI）
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。
K261037780 nm SPY 携帶式手持式成像 (SPY-PHI) 系統Stryker EndoscopyK253181SURGIMAGE SIM 1000H 荧光影像平台Surgimage CorporationK243645IC-Flow™影像系統 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986模斯IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003)；EXPLORER AIR® 無菌覆蓋 (8004)Surgvision GmbH
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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