FDA 510(k)

VORTRAN GO2VENT 配備 PEEP 阀

K 號：K202219 · 2021-02-11

決定日期2021-02-11

產品代碼BTL

諮詢委員會AN

決定相當於

器材摘要

VORTRAN GO2VENT with PEEP Valve is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2021-02-11 under 510(k) number K202219. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VORTRAN GO2VENT with PEEP Valve?

VORTRAN GO2VENT with PEEP Valve is a medical device that received FDA 510(k) clearance on 2021-02-11. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K202219.

When did VORTRAN GO2VENT with PEEP Valve receive FDA 510(k) clearance?

VORTRAN GO2VENT with PEEP Valve received FDA 510(k) clearance on 2021-02-11, under 510(k) number K202219.

Who is the listed applicant for VORTRAN GO2VENT with PEEP Valve?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VORTRAN GO2VENT with PEEP Valve?

The FDA product code for VORTRAN GO2VENT with PEEP Valve is BTL.

其他以 Vortran Medical Technology 1, 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。

K182292VORTRAN APM-Plus K173914VORTRAN 腕帶充氣器（VCI）K162968VORTRAN GO2VENT K153733VORTRAN 血壓計

相關器械（代碼：BTL）

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。

K242769VentStar Resus 加熱式（N）（MP17030）；VentStar Autobreath 加熱式（N）（MP17031）Draegerwerk AG & CO Kgaa K221634Oxymag - 車輛及緊急呼吸器Magnamed Tecnologia Medica S/A K193191MEDUMAT Easy CPR，MEDUMAT Easy CPR 配袋Weinmann Emergency Medical Technology GmbH + Co. KG K182956Puffin Lite嬰兒復甦系統International Biomedical K173373安全T型復甦器Ventlab, LLC K161420移動SLCThornhill Research, Inc.

官方來源

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