FDA 510(k)

EvaQMax煙霧排風系統

K 號：K192035 · 2019-08-29

決定日期2019-08-29

產品代碼FYD

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

EvaQMax Smoke Evacuation System is the device name listed in this FDA 510(k) record. The listed applicant is Bio Protech, Inc.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K192035. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EvaQMax Smoke Evacuation System?

EvaQMax Smoke Evacuation System is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Bio Protech, Inc.. The 510(k) number is K192035.

When did EvaQMax Smoke Evacuation System receive FDA 510(k) clearance?

EvaQMax Smoke Evacuation System received FDA 510(k) clearance on 2019-08-29, under 510(k) number K192035.

Who is the listed applicant for EvaQMax Smoke Evacuation System?

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

What is the FDA product code for EvaQMax Smoke Evacuation System?

The FDA product code for EvaQMax Smoke Evacuation System is FYD.

其他以 Bio Protech, Inc. 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。

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相關器械（代碼：FYD）

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

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