NuEra 紧密，NuEra 紧密 EMS
K号: K200359 · 2020-08-11
广告
器械摘要
NuEra Tight, NuEra Tight EMS is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2020-08-11 under 510(k) number K200359. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NuEra Tight, NuEra Tight EMS?
NuEra Tight, NuEra Tight EMS is a medical device that received FDA 510(k) clearance on 2020-08-11. The listed applicant is Bios S.R.L.. The 510(k) number is K200359.
When did NuEra Tight, NuEra Tight EMS receive FDA 510(k) clearance?
NuEra Tight, NuEra Tight EMS received FDA 510(k) clearance on 2020-08-11, under 510(k) number K200359.
Who is the listed applicant for NuEra Tight, NuEra Tight EMS?
The FDA 510(k) record lists Bios S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NuEra Tight, NuEra Tight EMS?
The FDA product code for NuEra Tight, NuEra Tight EMS is PBX.
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Bios S.R.L.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：PBX）
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