ELMED 開放式內視鏡儀器及附件
K 號：K181173 · 2019-03-22
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器材摘要
ELMED Laparoscopic Instruments and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Elmed Incorporated. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181173. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ELMED Laparoscopic Instruments and Accessories?
ELMED Laparoscopic Instruments and Accessories is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Elmed Incorporated. The 510(k) number is K181173.
When did ELMED Laparoscopic Instruments and Accessories receive FDA 510(k) clearance?
ELMED Laparoscopic Instruments and Accessories received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181173.
Who is the listed applicant for ELMED Laparoscopic Instruments and Accessories?
The FDA 510(k) record lists Elmed Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELMED Laparoscopic Instruments and Accessories?
The FDA product code for ELMED Laparoscopic Instruments and Accessories is GCJ.
相關臨床試驗
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相關器械（代碼：GCJ）
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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