CoSense ETCO 監護儀
K 號：K253119 · 2026-05-29
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器材摘要
CoSense ETCO Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Capnia, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K253119. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CoSense ETCO Monitor?
CoSense ETCO Monitor is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Capnia, Inc.. The 510(k) number is K253119.
When did CoSense ETCO Monitor receive FDA 510(k) clearance?
CoSense ETCO Monitor received FDA 510(k) clearance on 2026-05-29, under 510(k) number K253119.
Who is the listed applicant for CoSense ETCO Monitor?
The FDA 510(k) record lists Capnia, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CoSense ETCO Monitor?
The FDA product code for CoSense ETCO Monitor is CCJ.
相關臨床試驗
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相關器械（代碼：CCJ）
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
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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