T-SHAPE 2
K号: K231092 · 2023-09-22
广告
决定日期2023-09-22
产品代码NUV
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
T-SHAPE 2 is the device name listed in this FDA 510(k) record. The listed applicant is B&M S.R.L. Marketing Nel Benessere. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231092. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the T-SHAPE 2?
T-SHAPE 2 is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is B&M S.R.L. Marketing Nel Benessere. The 510(k) number is K231092.
When did T-SHAPE 2 receive FDA 510(k) clearance?
T-SHAPE 2 received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231092.
Who is the listed applicant for T-SHAPE 2?
The FDA 510(k) record lists B&M S.R.L. Marketing Nel Benessere as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for T-SHAPE 2?
The FDA product code for T-SHAPE 2 is NUV.
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。
相关器械（代码：NUV）
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。
广告