FDA 510(k)微波消融系统
K号: K183153 · 2019-07-08
决定日期2019-07-08
产品代码NEY
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Microwave Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K183153. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Microwave Ablation System?
Microwave Ablation System is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K183153.
When did Microwave Ablation System receive FDA 510(k) clearance?
Microwave Ablation System received FDA 510(k) clearance on 2019-07-08, under 510(k) number K183153.
Who is the listed applicant for Microwave Ablation System?
The FDA 510(k) record lists Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Microwave Ablation System?
The FDA product code for Microwave Ablation System is NEY.
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列明Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.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。
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相关器械（代码：NEY）
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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