外科顯微鏡（OMS2360、OMS2380）
K 號：K252464 · 2026-04-28
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器材摘要
Surgical Microscope (OMS2360, OMS2380) is the device name listed in this FDA 510(k) record. The listed applicant is Zumax Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-28 under 510(k) number K252464. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Surgical Microscope (OMS2360, OMS2380)?
Surgical Microscope (OMS2360, OMS2380) is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is Zumax Medical Co., Ltd.. The 510(k) number is K252464.
When did Surgical Microscope (OMS2360, OMS2380) receive FDA 510(k) clearance?
Surgical Microscope (OMS2360, OMS2380) received FDA 510(k) clearance on 2026-04-28, under 510(k) number K252464.
Who is the listed applicant for Surgical Microscope (OMS2360, OMS2380)?
The FDA 510(k) record lists Zumax Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Surgical Microscope (OMS2360, OMS2380)?
The FDA product code for Surgical Microscope (OMS2360, OMS2380) is NBL.
相關臨床試驗
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相關器械（代碼：NBL）
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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