AK 身体塑形设备
K号: K152420 · 2016-12-01
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决定日期2016-12-01
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
AK Body Toning Device is the device name listed in this FDA 510(k) record. The listed applicant is Ak Beauty Enterprises, LLC. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K152420. 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 AK Body Toning Device?
AK Body Toning Device is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Ak Beauty Enterprises, LLC. The 510(k) number is K152420.
When did AK Body Toning Device receive FDA 510(k) clearance?
AK Body Toning Device received FDA 510(k) clearance on 2016-12-01, under 510(k) number K152420.
Who is the listed applicant for AK Body Toning Device?
The FDA 510(k) record lists Ak Beauty Enterprises, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AK Body Toning Device?
The FDA product code for AK Body Toning Device is NGX.
相关临床试验
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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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