CONTEC 氧氣濃縮機
K 號：K180837 · 2019-01-10
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器材摘要
CONTEC Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K180837. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CONTEC Oxygen Concentrator?
CONTEC Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K180837.
When did CONTEC Oxygen Concentrator receive FDA 510(k) clearance?
CONTEC Oxygen Concentrator received FDA 510(k) clearance on 2019-01-10, under 510(k) number K180837.
Who is the listed applicant for CONTEC Oxygen Concentrator?
The FDA 510(k) record lists Contec Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CONTEC Oxygen Concentrator?
The FDA product code for CONTEC Oxygen Concentrator is CAW.
相關臨床試驗
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相關器械（代碼：CAW）
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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