FDA 510(k)

NuEra 紧密射频型号 OptiStream

K号: K230755 · 2023-10-30

决定日期2023-10-30

产品代码PBX

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决定实质等同

器械摘要

NuEra Tight RF Model OptiStream 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 2023-10-30 under 510(k) number K230755. 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 RF Model OptiStream?

NuEra Tight RF Model OptiStream is a medical device that received FDA 510(k) clearance on 2023-10-30. The listed applicant is Bios S.R.L.. The 510(k) number is K230755.

When did NuEra Tight RF Model OptiStream receive FDA 510(k) clearance?

NuEra Tight RF Model OptiStream received FDA 510(k) clearance on 2023-10-30, under 510(k) number K230755.

Who is the listed applicant for NuEra Tight RF Model OptiStream?

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 RF Model OptiStream?

The FDA product code for NuEra Tight RF Model OptiStream is PBX.

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。

K243445Splendor X（Alex，Alex2，Nd:YAG，Alex+Nd:YAG）K241407Splendor X（Alex，Alex2，Nd:YAG，Alex+Nd:YAG）K223856NuEra 紧密射频系列 K223907NuEra 紧密射频型号 APMD145.M70-US K210867NuEra 紧密射频，NuEra 紧密射频加 K201239NuEra 紧密系列，EMS 型号

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官方来源

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