PlanOne 1
K 號：K250963 · 2025-11-20
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器材摘要
PlanOne 1 is the device name listed in this FDA 510(k) record. The listed applicant is Cosylab Jsc, Control System Laboratory. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K250963. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PlanOne 1?
PlanOne 1 is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Cosylab Jsc, Control System Laboratory. The 510(k) number is K250963.
When did PlanOne 1 receive FDA 510(k) clearance?
PlanOne 1 received FDA 510(k) clearance on 2025-11-20, under 510(k) number K250963.
Who is the listed applicant for PlanOne 1?
The FDA 510(k) record lists Cosylab Jsc, Control System Laboratory as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PlanOne 1?
The FDA product code for PlanOne 1 is MUJ.
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相關器械（代碼：MUJ）
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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