OnyxCeph 医療設備規範文本 OnyxCeph 医療設備已通過FDA認證，符合510(k)規定，並獲得PMA許可。該設備的NCT編號為[識別號]，PMID編號為[識別號]。請參考以下URL獲取更多資訊：[URL]。
K 號：K213263 · 2023-01-04
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器材摘要
OnyxCeph is the device name listed in this FDA 510(k) record. The listed applicant is Image Instruments GmbH. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K213263. 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 OnyxCeph?
OnyxCeph is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Image Instruments GmbH. The 510(k) number is K213263.
When did OnyxCeph receive FDA 510(k) clearance?
OnyxCeph received FDA 510(k) clearance on 2023-01-04, under 510(k) number K213263.
Who is the listed applicant for OnyxCeph?
The FDA 510(k) record lists Image Instruments GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OnyxCeph?
The FDA product code for OnyxCeph 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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