EXPLORER AIR® II
K 號：K222240 · 2023-02-28
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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 2023-02-28 under 510(k) number K222240. 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 2023-02-28. The listed applicant is Surgvision GmbH. The 510(k) number is K222240.
When did EXPLORER AIR® II receive FDA 510(k) clearance?
EXPLORER AIR® II received FDA 510(k) clearance on 2023-02-28, under 510(k) number K222240.
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
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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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