元素顆粒
K 號：K241283 · 2025-01-03
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器材摘要
Elemental Granulate is the device name listed in this FDA 510(k) record. The listed applicant is Zinkh NV. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K241283. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.
常見問題
What is the Elemental Granulate?
Elemental Granulate is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Zinkh NV. The 510(k) number is K241283.
When did Elemental Granulate receive FDA 510(k) clearance?
Elemental Granulate received FDA 510(k) clearance on 2025-01-03, under 510(k) number K241283.
Who is the listed applicant for Elemental Granulate?
The FDA 510(k) record lists Zinkh NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Elemental Granulate?
The FDA product code for Elemental Granulate is OLR.
相關臨床試驗
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相關器械（代碼：OLR）
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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