德米超級
K 號：K163064 · 2017-07-18
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器材摘要
Demi Ultra is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K163064. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Demi Ultra?
Demi Ultra is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Kerr Corporation. The 510(k) number is K163064.
When did Demi Ultra receive FDA 510(k) clearance?
Demi Ultra received FDA 510(k) clearance on 2017-07-18, under 510(k) number K163064.
Who is the listed applicant for Demi Ultra?
The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Demi Ultra?
The FDA product code for Demi Ultra is EBZ.
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其他以 Kerr Corporation 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：EBZ）
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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