終端醫療設備規範文本 終端醫療設備註冊資料 公司/產品名稱：Endotics FDA（美國食品藥品管理局）：美國食品藥品管理局 510(k)：510(k)註冊 PMA：上市前批准 NCT：臨床試驗登錄識別碼 PMID：PubMed識別碼 識別碼：識別碼 URL：網址
K 號：K190669 · 2020-01-03
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器材摘要
Endotics is the device name listed in this FDA 510(k) record. The listed applicant is Era Endoscopy S.R.L.. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K190669. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Endotics?
Endotics is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Era Endoscopy S.R.L.. The 510(k) number is K190669.
When did Endotics receive FDA 510(k) clearance?
Endotics received FDA 510(k) clearance on 2020-01-03, under 510(k) number K190669.
Who is the listed applicant for Endotics?
The FDA 510(k) record lists Era Endoscopy S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endotics?
The FDA product code for Endotics is FDF.
相關臨床試驗
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：FDF）
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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