ViaTherm 增强型
K号: K173300 · 2018-05-01
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决定日期2018-05-01
产品代码IMJ
咨询委员会PM
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决定实质等同
器械摘要
ViaTherm BOOST is the device name listed in this FDA 510(k) record. The listed applicant is Viatherm Therapeutics, LLC. It received FDA 510(k) clearance on 2018-05-01 under 510(k) number K173300. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ViaTherm BOOST?
ViaTherm BOOST is a medical device that received FDA 510(k) clearance on 2018-05-01. The listed applicant is Viatherm Therapeutics, LLC. The 510(k) number is K173300.
When did ViaTherm BOOST receive FDA 510(k) clearance?
ViaTherm BOOST received FDA 510(k) clearance on 2018-05-01, under 510(k) number K173300.
Who is the listed applicant for ViaTherm BOOST?
The FDA 510(k) record lists Viatherm Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ViaTherm BOOST?
The FDA product code for ViaTherm BOOST is IMJ.
相关临床试验
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列明Viatherm Therapeutics, LLC为申报人的其他记录
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相关器械（代码：IMJ）
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。
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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