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FDA 510(k)

耐久ETCO2/02鼻管

K 號:K213767 · 2023-09-12

決定日期2023-09-12
產品代碼CCK
諮詢委員會AN
決定相當於

器材摘要

Endure ETCO2/02 Nasal Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Endure Industries, Inc.. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K213767. 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 Endure ETCO2/02 Nasal Cannula?

Endure ETCO2/02 Nasal Cannula is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Endure Industries, Inc.. The 510(k) number is K213767.

When did Endure ETCO2/02 Nasal Cannula receive FDA 510(k) clearance?

Endure ETCO2/02 Nasal Cannula received FDA 510(k) clearance on 2023-09-12, under 510(k) number K213767.

Who is the listed applicant for Endure ETCO2/02 Nasal Cannula?

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

What is the FDA product code for Endure ETCO2/02 Nasal Cannula?

The FDA product code for Endure ETCO2/02 Nasal Cannula is CCK.

相關臨床試驗

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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。

官方來源

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