內視鏡氧氣面罩
K 號：K220533 · 2022-11-16
廣告
器材摘要
Endoscopy Oxygen Mask is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K220533. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Endoscopy Oxygen Mask?
Endoscopy Oxygen Mask is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Engineered Medical Systems, Inc.. The 510(k) number is K220533.
When did Endoscopy Oxygen Mask receive FDA 510(k) clearance?
Endoscopy Oxygen Mask received FDA 510(k) clearance on 2022-11-16, under 510(k) number K220533.
Who is the listed applicant for Endoscopy Oxygen Mask?
The FDA 510(k) record lists Engineered Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endoscopy Oxygen Mask?
The FDA product code for Endoscopy Oxygen Mask is CCK.
相關臨床試驗
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。
相關器械（代碼：CCK）
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。
K251641GF-310R 多氣體單元（GF-310R）Nihon Kohden CorporationK261633視覺呼吸Affirm Medical Technologies II, LLCK253030Capnostream™35 輕便呼吸監測器 (PM35MN)Covidien, LLCK250148醫療氣體分析儀（AG200）Prior Care Science Technology, Ltd.K243956TG-980P 二氧化碳感測器套件（TG-980P）；TG-980P1 二氧化碳感測器套件（TG-980P1）Nihon Kohden CorporationK2512160184 CO2 標本採集管；0184T CO2 標本採集管；0139 CO2 標本採集管；0182 CO2 標本採集管Barbaras Development, Inc.
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。
廣告