VORTRAN GO2VENT
K号: K162968 · 2017-04-10
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决定日期2017-04-10
产品代码BTL
咨询委员会AN
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器械摘要
VORTRAN GO2VENT 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 2017-04-10 under 510(k) number K162968. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VORTRAN GO2VENT?
VORTRAN GO2VENT is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K162968.
When did VORTRAN GO2VENT receive FDA 510(k) clearance?
VORTRAN GO2VENT received FDA 510(k) clearance on 2017-04-10, under 510(k) number K162968.
Who is the listed applicant for VORTRAN GO2VENT?
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?
The FDA product code for VORTRAN GO2VENT is BTL.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Vortran Medical Technology 1, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：BTL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K242769VentStar Resus加热型（N）（MP17030）；VentStar Autobreath加热型（N）（MP17031）Draegerwerk AG & CO KgaaK221634Oxymag - 运输和紧急呼吸器Magnamed Tecnologia Medica S/AK202219VORTRAN GO2VENT 带有呼气末正压（PEEP）阀Vortran Medical Technology 1, Inc.K193191MEDUMAT Easy CPR，MEDUMAT Easy CPR 带袋Weinmann Emergency Medical Technology GmbH + Co. KGK182956Puffin Lite 婴儿复苏系统International BiomedicalK173373SafeT T形复苏器Ventlab, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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