FDA 510(k)

維恩圖斯/哨兵套件產品線

K 號：K183567 · 2019-08-23

決定日期2019-08-23

產品代碼BZC

諮詢委員會AN

決定相當於

器材摘要

Vyntus/SentrySuite Product Line is the device name listed in this FDA 510(k) record. The listed applicant is Vyaire Medical. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K183567. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vyntus/SentrySuite Product Line?

Vyntus/SentrySuite Product Line is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Vyaire Medical. The 510(k) number is K183567.

When did Vyntus/SentrySuite Product Line receive FDA 510(k) clearance?

Vyntus/SentrySuite Product Line received FDA 510(k) clearance on 2019-08-23, under 510(k) number K183567.

Who is the listed applicant for Vyntus/SentrySuite Product Line?

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 Vyntus/SentrySuite Product Line?

The FDA product code for Vyntus/SentrySuite Product Line is BZC.

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。

K170378AirLife 成人加熱線雙相輔助通氣/無創性呼吸治療器電路

相關器械（代碼：BZC）

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。

K240293STS 請注意，這裡的 "STS" 似乎是一個設備名稱或識別碼，並未提供完整的文檔內容，因此無法進行完整的翻譯。如果您能提供完整的文檔內容，我將能夠提供正確的翻譯。Techbopulm, Ltd.K190853維恩塔斯BODYVyaire Medical, Inc.K181524Vyntus ONE 配 CART，Vyntus ONE PFT 只配 CART，Vyntus ONE 配可調節 CART，Vyntus ONE PFT 只配可調節 CARTVyaire Medical, Inc.K162515COSMED K5 穿著式代謝技術Cosmed Srl K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

官方來源

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