FDA 510(k)

MagVenture TMS Atlas神经导航系统

K号: K221544 · 2023-03-17

决定日期2023-03-17

产品代码HAW

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决定实质等同

器械摘要

MagVenture TMS Atlas Neuro Navigation System 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 2023-03-17 under 510(k) number K221544. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MagVenture TMS Atlas Neuro Navigation System?

MagVenture TMS Atlas Neuro Navigation System is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K221544.

When did MagVenture TMS Atlas Neuro Navigation System receive FDA 510(k) clearance?

MagVenture TMS Atlas Neuro Navigation System received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221544.

Who is the listed applicant for MagVenture TMS Atlas Neuro Navigation System?

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 TMS Atlas Neuro Navigation System?

The FDA product code for MagVenture TMS Atlas Neuro Navigation System is HAW.

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 K193006MagVenture TMS治疗 - 用于治疗OCD，MagVenture TMS治疗系统

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