FDA 510(k)

Mag Vita TMS治疗系统带Theta Burst刺激

K号: K173620 · 2018-08-14

决定日期2018-08-14

产品代码OBP

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决定实质等同

器械摘要

Mag Vita TMS Therapy System w/Theta Burst Stimulation 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 2018-08-14 under 510(k) number K173620. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mag Vita TMS Therapy System w/Theta Burst Stimulation?

Mag Vita TMS Therapy System w/Theta Burst Stimulation is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K173620.

When did Mag Vita TMS Therapy System w/Theta Burst Stimulation receive FDA 510(k) clearance?

Mag Vita TMS Therapy System w/Theta Burst Stimulation received FDA 510(k) clearance on 2018-08-14, under 510(k) number K173620.

Who is the listed applicant for Mag Vita TMS Therapy System w/Theta Burst Stimulation?

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 Mag Vita TMS Therapy System w/Theta Burst Stimulation?

The FDA product code for Mag Vita TMS Therapy System w/Theta Burst Stimulation is OBP.

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-)K230014MagVenture疼痛治疗：MagPro R30，MagPro R30带MagOption，MagPro X100，MagPro X100带MagOption K221544MagVenture TMS Atlas神经导航系统

查看所有 14 个设备 →

官方来源

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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。