ZeeroMED 觀察器
K 號：K200546 · 2020-05-05
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器材摘要
ZeeroMED View is the device name listed in this FDA 510(k) record. The listed applicant is O3 Enterprise Srl. It received FDA 510(k) clearance on 2020-05-05 under 510(k) number K200546. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ZeeroMED View?
ZeeroMED View is a medical device that received FDA 510(k) clearance on 2020-05-05. The listed applicant is O3 Enterprise Srl. The 510(k) number is K200546.
When did ZeeroMED View receive FDA 510(k) clearance?
ZeeroMED View received FDA 510(k) clearance on 2020-05-05, under 510(k) number K200546.
Who is the listed applicant for ZeeroMED View?
The FDA 510(k) record lists O3 Enterprise Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZeeroMED View?
The FDA product code for ZeeroMED View is LLZ.
相關臨床試驗
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相關器械（代碼：LLZ）
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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