醫用二極雷射系統
K 號：K160549 · 2017-04-07
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決定日期2017-04-07
產品代碼GEX
諮詢委員會SU
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決定相當於
器材摘要
MEDICAL DIODE LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Gigaa Optronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K160549. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the MEDICAL DIODE LASER SYSTEMS?
MEDICAL DIODE LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Wuhan Gigaa Optronics Technology Co., Ltd.. The 510(k) number is K160549.
When did MEDICAL DIODE LASER SYSTEMS receive FDA 510(k) clearance?
MEDICAL DIODE LASER SYSTEMS received FDA 510(k) clearance on 2017-04-07, under 510(k) number K160549.
Who is the listed applicant for MEDICAL DIODE LASER SYSTEMS?
The FDA 510(k) record lists Wuhan Gigaa Optronics Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MEDICAL DIODE LASER SYSTEMS?
The FDA product code for MEDICAL DIODE LASER SYSTEMS is GEX. This falls under the Gastroenterology category.
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：GEX）
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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