CivaDerm
K 號：K191324 · 2019-09-20
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器材摘要
CivaDerm is the device name listed in this FDA 510(k) record. The listed applicant is Civatech Oncology, Inc.. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K191324. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CivaDerm?
CivaDerm is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Civatech Oncology, Inc.. The 510(k) number is K191324.
When did CivaDerm receive FDA 510(k) clearance?
CivaDerm received FDA 510(k) clearance on 2019-09-20, under 510(k) number K191324.
Who is the listed applicant for CivaDerm?
The FDA 510(k) record lists Civatech Oncology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CivaDerm?
The FDA product code for CivaDerm is KXK.
相關臨床試驗
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相關器械（代碼：KXK）
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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