A-FIT
K 號：K173676 · 2018-09-14
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器材摘要
A-FIT is the device name listed in this FDA 510(k) record. The listed applicant is Hironic Co., Ltd.. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K173676. 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 A-FIT?
A-FIT is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Hironic Co., Ltd.. The 510(k) number is K173676.
When did A-FIT receive FDA 510(k) clearance?
A-FIT received FDA 510(k) clearance on 2018-09-14, under 510(k) number K173676.
Who is the listed applicant for A-FIT?
FDA 510(k) 記錄將 Hironic Co., Ltd. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for A-FIT?
The FDA product code for A-FIT is GEX. This falls under the Gastroenterology category.
其他以 Hironic Co., Ltd. 為申請人之記錄
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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
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