VORTRAN GO2VENT 带有呼气末正压（PEEP）阀
K号: K202219 · 2021-02-11
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决定日期2021-02-11
产品代码BTL
咨询委员会AN
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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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。
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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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