XiniWave II 型号 ECS322P
K号: K171092 · 2017-07-10
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决定日期2017-07-10
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
XiniWave II Model ECS322P is the device name listed in this FDA 510(k) record. The listed applicant is International Trade Group, Inc.. It received FDA 510(k) clearance on 2017-07-10 under 510(k) number K171092. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XiniWave II Model ECS322P?
XiniWave II Model ECS322P is a medical device that received FDA 510(k) clearance on 2017-07-10. The listed applicant is International Trade Group, Inc.. The 510(k) number is K171092.
When did XiniWave II Model ECS322P receive FDA 510(k) clearance?
XiniWave II Model ECS322P received FDA 510(k) clearance on 2017-07-10, under 510(k) number K171092.
Who is the listed applicant for XiniWave II Model ECS322P?
The FDA 510(k) record lists International Trade Group, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XiniWave II Model ECS322P?
The FDA product code for XiniWave II Model ECS322P is NGX.
相关临床试验
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列明International Trade Group, 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：NGX）
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
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