Nexcore GI 空氣充氣器
K 號：K162332 · 2016-09-29
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器材摘要
Nexcore GI Insufflator is the device name listed in this FDA 510(k) record. The listed applicant is Nexcore Technology, LLC. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K162332. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Nexcore GI Insufflator?
Nexcore GI Insufflator is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Nexcore Technology, LLC. The 510(k) number is K162332.
When did Nexcore GI Insufflator receive FDA 510(k) clearance?
Nexcore GI Insufflator received FDA 510(k) clearance on 2016-09-29, under 510(k) number K162332.
Who is the listed applicant for Nexcore GI Insufflator?
The FDA 510(k) record lists Nexcore Technology, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nexcore GI Insufflator?
The FDA product code for Nexcore GI Insufflator is FCX.
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相關器械（代碼：FCX）
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。
官方來源
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