Zeta 頭部導航系統
K 號：K230661 · 2023-09-08
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器材摘要
Zeta Cranial Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Zeta Surgical. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K230661. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Zeta Cranial Navigation System?
Zeta Cranial Navigation System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Zeta Surgical. The 510(k) number is K230661.
When did Zeta Cranial Navigation System receive FDA 510(k) clearance?
Zeta Cranial Navigation System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K230661.
Who is the listed applicant for Zeta Cranial Navigation System?
The FDA 510(k) record lists Zeta Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zeta Cranial Navigation System?
The FDA product code for Zeta Cranial Navigation System is HAW.
相關臨床試驗
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相關器械（代碼：HAW）
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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