FDA 510(k)

マグベンチャーTMSセラピー – OCDの治療用、マグベンチャーTMSセラピーシステム

K番号: K193006 · 2020-08-09

決定日2020-08-09

製品コードQCI

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy 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 2020-08-09 under 510(k) number K193006. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is a medical device that received FDA 510(k) clearance on 2020-08-09. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K193006.

When did MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system receive FDA 510(k) clearance?

MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system received FDA 510(k) clearance on 2020-08-09, under 510(k) number K193006.

Who is the listed applicant for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy 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 Therapy – for treatment of OCD, MagVenture TMS Therapy system?

The FDA product code for MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system is QCI.

申請者としてTonica Elektronik A/Sを記載するその他の記録

K260189マグベンチャー・アcelerated TMS（aTMS）治療システム K251125マグベンチャーTMSセラピーシステム K251119マグベンチャーTMSセラピーシステム K252032T65 （9016E061-）K230014マグベンチャー痛み治療：マグプロR30、マグプロR30（マグオプション付き）、マグプロX100、マグプロX100（マグオプション付き）K221544マグベンチャー TMS アトラスネウロナビゲーションシステム

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