FDA 510(k)

MagVenture疼痛治疗：MagPro R30，MagPro R30带MagOption，MagPro X100，MagPro X100带MagOption

K号: K230014 · 2023-08-25

决定日期2023-08-25

产品代码QPL

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K230014. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K230014.

When did MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption receive FDA 510(k) clearance?

MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230014.

Who is the listed applicant for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption?

The FDA product code for MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption is QPL.

列明Tonica Elektronik A/S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。

K260189MagVenture加速TMS（aTMS）治疗系统 K251125MagVenture TMS治疗系统 K251119MagVenture TMS治疗系统 K252032T65 (9016E061-)K221544MagVenture TMS Atlas神经导航系统 K193006MagVenture TMS治疗 - 用于治疗OCD，MagVenture TMS治疗系统

查看所有 14 个设备 →

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。