CORE1 嵌入系統
K 號：K210039 · 2022-01-07
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器材摘要
CORE1 Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Cybermed, Inc.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K210039. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CORE1 Implant System?
CORE1 Implant System is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Cybermed, Inc.. The 510(k) number is K210039.
When did CORE1 Implant System receive FDA 510(k) clearance?
CORE1 Implant System received FDA 510(k) clearance on 2022-01-07, under 510(k) number K210039.
Who is the listed applicant for CORE1 Implant System?
The FDA 510(k) record lists Cybermed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CORE1 Implant System?
The FDA product code for CORE1 Implant System is DZE.
相關臨床試驗
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相關器械（代碼：DZE）
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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