VPS 印象材質
K 號：K191034 · 2019-09-04
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器材摘要
VPS Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Hygedent, Inc.. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K191034. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the VPS Impression Material?
VPS Impression Material is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Hygedent, Inc.. The 510(k) number is K191034.
When did VPS Impression Material receive FDA 510(k) clearance?
VPS Impression Material received FDA 510(k) clearance on 2019-09-04, under 510(k) number K191034.
Who is the listed applicant for VPS Impression Material?
The FDA 510(k) record lists Hygedent, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VPS Impression Material?
The FDA product code for VPS Impression Material is ELW.
相關臨床試驗
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其他以 Hygedent, 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：ELW）
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
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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