Idys ALIF 3DTi
K 號:K200919 · 2021-04-12
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器材摘要
Idys ALIF 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K200919. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Idys ALIF 3DTi?
Idys ALIF 3DTi is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Clariance. The 510(k) number is K200919.
When did Idys ALIF 3DTi receive FDA 510(k) clearance?
Idys ALIF 3DTi received FDA 510(k) clearance on 2021-04-12, under 510(k) number K200919.
Who is the listed applicant for Idys ALIF 3DTi?
The FDA 510(k) record lists Clariance as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Idys ALIF 3DTi?
The FDA product code for Idys ALIF 3DTi is MAX.
其他以 Clariance 為申請人之記錄
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相關器械(代碼:MAX)
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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官方來源
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