FDA 510(k)

生物保護空氣/水及吸引閥

K 號：K192059 · 2019-09-17

決定日期2019-09-17

產品代碼ODC

諮詢委員會GU

決定相當於

器材摘要

Bio Guard Air/Water & Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K192059. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bio Guard Air/Water & Suction Valves?

Bio Guard Air/Water & Suction Valves is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K192059.

When did Bio Guard Air/Water & Suction Valves receive FDA 510(k) clearance?

Bio Guard Air/Water & Suction Valves received FDA 510(k) clearance on 2019-09-17, under 510(k) number K192059.

Who is the listed applicant for Bio Guard Air/Water & Suction Valves?

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

What is the FDA product code for Bio Guard Air/Water & Suction Valves?

The FDA product code for Bio Guard Air/Water & Suction Valves is ODC.

其他以 United States Endoscopy Group, Inc. 為申請人之記錄

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相關器械（代碼：ODC）

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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