iovera系统
K号: K161835 · 2017-03-24
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决定日期2017-03-24
产品代码GXH
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
iovera system is the device name listed in this FDA 510(k) record. The listed applicant is Myoscience, Inc.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K161835. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iovera system?
iovera system is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Myoscience, Inc.. The 510(k) number is K161835.
When did iovera system receive FDA 510(k) clearance?
iovera system received FDA 510(k) clearance on 2017-03-24, under 510(k) number K161835.
Who is the listed applicant for iovera system?
The FDA 510(k) record lists Myoscience, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iovera system?
The FDA product code for iovera system is GXH.
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Myoscience, 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：GXH）
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。
K250371cryoICE cryoXT 冷冻消融探头（cryoXT）AtriCure, Inc.K243677iovera° 系统Pacira Biosciences, Inc.K243157AtriCure cryoICE BOX (ACM)AtriCure, Inc.K233170cryoICE cryoSPHERE+ 冷冻消融探头（CRYOSP）；cryoICE cryoSPHERE+ 冷冻消融探头（CRYOSP-L）；cryoICE cryoSPHERE MAX 冷冻消融探头（CRYOSMAX）；cryoICE cryoSPHERE MAX 冷冻消融探头（CRYOSMAX-L）AtriCure, Inc.K220656iovera 系统Pacira Biosciences, Inc.K211334Iovera系统Pacira Pharmaceuticals, Inc.
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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