TN-Brush
K号: K170596 · 2017-09-11
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决定日期2017-09-11
产品代码ELB
咨询委员会DE
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决定实质等同
器械摘要
TN-Brush is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2017-09-11 under 510(k) number K170596. The device is classified under product code ELB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TN-Brush?
TN-Brush is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K170596.
When did TN-Brush receive FDA 510(k) clearance?
TN-Brush received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170596.
Who is the listed applicant for TN-Brush?
The FDA 510(k) record lists Genoss Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TN-Brush?
The FDA product code for TN-Brush is ELB.
相关临床试验
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列明Genoss 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。
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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