NeuroBlate 系统
K号: K193375 · 2020-01-03
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器械摘要
NeuroBlate System is the device name listed in this FDA 510(k) record. The listed applicant is Monteris Medical,. It received FDA 510(k) clearance on 2020-01-03 under 510(k) number K193375. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
什么是NeuroBlate系统？
NeuroBlate System is a medical device that received FDA 510(k) clearance on 2020-01-03. The listed applicant is Monteris Medical,. The 510(k) number is K193375.
NeuroBlate系统何时获得FDA 510(k)批准？
NeuroBlate System received FDA 510(k) clearance on 2020-01-03, under 510(k) number K193375.
NeuroBlate系统列出的申请人是谁？
The FDA 510(k) record lists Monteris Medical, as the applicant. This does not by itself establish the device manufacturer.
什么是NeuroBlate系统的FDA产品代码？
The FDA product code for NeuroBlate System is GEX. This falls under the Gastroenterology category.
相关临床试验
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列明Monteris Medical,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：GEX）
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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