InnoVoyce 激光纖維
K 號：K220793 · 2022-05-25
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器材摘要
InnoVoyce Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Innovoyce, LLC. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220793. 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 InnoVoyce Laser Fiber?
InnoVoyce Laser Fiber is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Innovoyce, LLC. The 510(k) number is K220793.
When did InnoVoyce Laser Fiber receive FDA 510(k) clearance?
InnoVoyce Laser Fiber received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220793.
Who is the listed applicant for InnoVoyce Laser Fiber?
The FDA 510(k) record lists Innovoyce, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for InnoVoyce Laser Fiber?
The FDA product code for InnoVoyce Laser Fiber is GEX. This falls under the Gastroenterology category.
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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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