FDA 510(k)

EndoChoice 水壺蓋灌流系統

K 號：K161482 · 2016-06-27

決定日期2016-06-27

產品代碼FEQ

諮詢委員會GU

決定相當於

器材摘要

EndoChoice Water Bottle Cap Irrigation System is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-06-27 under 510(k) number K161482. The device is classified under product code FEQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoChoice Water Bottle Cap Irrigation System?

EndoChoice Water Bottle Cap Irrigation System is a medical device that received FDA 510(k) clearance on 2016-06-27. The listed applicant is Endochoice, Inc.. The 510(k) number is K161482.

When did EndoChoice Water Bottle Cap Irrigation System receive FDA 510(k) clearance?

EndoChoice Water Bottle Cap Irrigation System received FDA 510(k) clearance on 2016-06-27, under 510(k) number K161482.

Who is the listed applicant for EndoChoice Water Bottle Cap Irrigation System?

The FDA 510(k) record lists Endochoice, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoChoice Water Bottle Cap Irrigation System?

The FDA product code for EndoChoice Water Bottle Cap Irrigation System is FEQ.

其他以 Endochoice, Inc. 為申請人之記錄

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。

K160275融合內視鏡系統搭配FuseBox處理器 K161167密封一次性活體切片閥 K160403SmartStart 空氣/水及吸引閥 K153588EndoChoice 水壺蓋系統 K151475EndoChoice Select 注射針

相關器械（代碼：FEQ）

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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