iCAC 裝置
K 號：K230223 · 2023-04-25
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器材摘要
iCAC Device is the device name listed in this FDA 510(k) record. The listed applicant is Bunkerhill, Inc.. It received FDA 510(k) clearance on 2023-04-25 under 510(k) number K230223. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iCAC Device?
iCAC Device is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Bunkerhill, Inc.. The 510(k) number is K230223.
When did iCAC Device receive FDA 510(k) clearance?
iCAC Device received FDA 510(k) clearance on 2023-04-25, under 510(k) number K230223.
Who is the listed applicant for iCAC Device?
The FDA 510(k) record lists Bunkerhill, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iCAC Device?
The FDA product code for iCAC Device is JAK.
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相關器械（代碼：JAK）
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。
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