SLENDERTONE Evolve Abs, 类型 735
K号: K203513 · 2021-02-10
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决定日期2021-02-10
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
SLENDERTONE Evolve Abs, Type 735 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2021-02-10 under 510(k) number K203513. 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 SLENDERTONE Evolve Abs, Type 735?
SLENDERTONE Evolve Abs, Type 735 is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K203513.
When did SLENDERTONE Evolve Abs, Type 735 receive FDA 510(k) clearance?
SLENDERTONE Evolve Abs, Type 735 received FDA 510(k) clearance on 2021-02-10, under 510(k) number K203513.
Who is the listed applicant for SLENDERTONE Evolve Abs, Type 735?
The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SLENDERTONE Evolve Abs, Type 735?
The FDA product code for SLENDERTONE Evolve Abs, Type 735 is NGX.
相关临床试验
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列明Bio-Medical Research, 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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