精準胃腸內科設備
K 號：K231422 · 2023-08-28
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器材摘要
Precision GI is the device name listed in this FDA 510(k) record. The listed applicant is Limaca Medical, Ltd.. It received FDA 510(k) clearance on 2023-08-28 under 510(k) number K231422. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Precision GI?
Precision GI is a medical device that received FDA 510(k) clearance on 2023-08-28. The listed applicant is Limaca Medical, Ltd.. The 510(k) number is K231422.
When did Precision GI receive FDA 510(k) clearance?
Precision GI received FDA 510(k) clearance on 2023-08-28, under 510(k) number K231422.
Who is the listed applicant for Precision GI?
The FDA 510(k) record lists Limaca Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Precision GI?
The FDA product code for Precision GI is FCG.
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相關器械（代碼：FCG）
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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