K2 行動式
K 號：K200693 · 2020-11-19
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器材摘要
K2 MOBILE is the device name listed in this FDA 510(k) record. The listed applicant is Hulaser, Inc.. It received FDA 510(k) clearance on 2020-11-19 under 510(k) number K200693. 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 K2 MOBILE?
K2 MOBILE is a medical device that received FDA 510(k) clearance on 2020-11-19. The listed applicant is Hulaser, Inc.. The 510(k) number is K200693.
When did K2 MOBILE receive FDA 510(k) clearance?
K2 MOBILE received FDA 510(k) clearance on 2020-11-19, under 510(k) number K200693.
Who is the listed applicant for K2 MOBILE?
The FDA 510(k) record lists Hulaser, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for K2 MOBILE?
The FDA product code for K2 MOBILE is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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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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