EMS雕塑机
K号: K232982 · 2024-11-25
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决定日期2024-11-25
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
EMS Sculpt Machine is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K232982. 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 EMS Sculpt Machine?
EMS Sculpt Machine is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Shandong Huamei Technology Co., Ltd.. The 510(k) number is K232982.
When did EMS Sculpt Machine receive FDA 510(k) clearance?
EMS Sculpt Machine received FDA 510(k) clearance on 2024-11-25, under 510(k) number K232982.
Who is the listed applicant for EMS Sculpt Machine?
The FDA 510(k) record lists Shandong Huamei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EMS Sculpt Machine?
The FDA product code for EMS Sculpt Machine is NGX.
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Shandong Huamei Technology 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。
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
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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