感知製造激光纖維醫療設備 FDA、510(k)、PMA、NCT、PMID、識別碼及網址 政策：醫療規範-v1
K 號：K213554 · 2022-02-02
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器材摘要
Sentient Manufacturing Laser Fiber is the device name listed in this FDA 510(k) record. The listed applicant is Sentient Manufacturing , LLC. It received FDA 510(k) clearance on 2022-02-02 under 510(k) number K213554. 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 Sentient Manufacturing Laser Fiber?
Sentient Manufacturing Laser Fiber is a medical device that received FDA 510(k) clearance on 2022-02-02. The listed applicant is Sentient Manufacturing , LLC. The 510(k) number is K213554.
When did Sentient Manufacturing Laser Fiber receive FDA 510(k) clearance?
Sentient Manufacturing Laser Fiber received FDA 510(k) clearance on 2022-02-02, under 510(k) number K213554.
Who is the listed applicant for Sentient Manufacturing Laser Fiber?
The FDA 510(k) record lists Sentient Manufacturing , LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sentient Manufacturing Laser Fiber?
The FDA product code for Sentient Manufacturing Laser Fiber 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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