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FDA 510(k)

AirLife 成人加熱線雙相輔助通氣/無創性呼吸治療器電路

K 號:K170378 · 2017-09-14

決定日期2017-09-14
產品代碼BZE
諮詢委員會AN
決定相當於

器材摘要

AirLife Adult Heated Wire BiPAP/NIV Circuit is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K170378. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AirLife Adult Heated Wire BiPAP/NIV Circuit?

AirLife Adult Heated Wire BiPAP/NIV Circuit is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Vyaire Medical. The 510(k) number is K170378.

When did AirLife Adult Heated Wire BiPAP/NIV Circuit receive FDA 510(k) clearance?

AirLife Adult Heated Wire BiPAP/NIV Circuit received FDA 510(k) clearance on 2017-09-14, under 510(k) number K170378.

Who is the listed applicant for AirLife Adult Heated Wire BiPAP/NIV Circuit?

The FDA 510(k) record lists Vyaire Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirLife Adult Heated Wire BiPAP/NIV Circuit?

The FDA product code for AirLife Adult Heated Wire BiPAP/NIV Circuit is BZE.

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。

其他以 Vyaire Medical 為申請人之記錄

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:BZE)

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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