奧米尼亞醫療 PsiF DNA™ 系統
K 號：K242431 · 2025-06-06
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器材摘要
Omnia Medical PsiF DNA™ System is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Medical, LLC. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K242431. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Omnia Medical PsiF DNA™ System?
Omnia Medical PsiF DNA™ System is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Omnia Medical, LLC. The 510(k) number is K242431.
When did Omnia Medical PsiF DNA™ System receive FDA 510(k) clearance?
Omnia Medical PsiF DNA™ System received FDA 510(k) clearance on 2025-06-06, under 510(k) number K242431.
Who is the listed applicant for Omnia Medical PsiF DNA™ System?
The FDA 510(k) record lists Omnia Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Omnia Medical PsiF DNA™ System?
The FDA product code for Omnia Medical PsiF DNA™ System is OUR.
相關臨床試驗
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其他以 Omnia Medical, LLC 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：OUR）
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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