iRoot SP Plus
K 號：K231259 · 2023-05-31
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器材摘要
iRoot SP Plus is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Bioceramix, Inc.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K231259. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iRoot SP Plus?
iRoot SP Plus is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Innovative Bioceramix, Inc.. The 510(k) number is K231259.
When did iRoot SP Plus receive FDA 510(k) clearance?
iRoot SP Plus received FDA 510(k) clearance on 2023-05-31, under 510(k) number K231259.
Who is the listed applicant for iRoot SP Plus?
The FDA 510(k) record lists Innovative Bioceramix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iRoot SP Plus?
The FDA product code for iRoot SP Plus is KIF.
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其他以 Innovative Bioceramix, Inc. 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：KIF）
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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