ORTIV（ORTIV-BL，ORTIV-WH）
K 號：K241646 · 2024-11-01
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器材摘要
ORTIV (ORTIV-BL, ORTIV-WH) is the device name listed in this FDA 510(k) record. The listed applicant is Mvitro Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K241646. 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 ORTIV (ORTIV-BL, ORTIV-WH)?
ORTIV (ORTIV-BL, ORTIV-WH) is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Mvitro Co., Ltd.. The 510(k) number is K241646.
When did ORTIV (ORTIV-BL, ORTIV-WH) receive FDA 510(k) clearance?
ORTIV (ORTIV-BL, ORTIV-WH) received FDA 510(k) clearance on 2024-11-01, under 510(k) number K241646.
Who is the listed applicant for ORTIV (ORTIV-BL, ORTIV-WH)?
The FDA 510(k) record lists Mvitro Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ORTIV (ORTIV-BL, ORTIV-WH)?
The FDA product code for ORTIV (ORTIV-BL, ORTIV-WH) 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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