FDA 510(k)

第2世代モナーク外用三叉神経刺激（eTNS）システム®

K番号: K233293 · 2024-01-16

決定日2024-01-16

製品コードQGL

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

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is the device name listed in this FDA 510(k) record. The listed applicant is Neurosigma, Inc.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K233293. The device is classified under product code QGL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Neurosigma, Inc.. The 510(k) number is K233293.

When did Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® receive FDA 510(k) clearance?

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® received FDA 510(k) clearance on 2024-01-16, under 510(k) number K233293.

Who is the listed applicant for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

The FDA 510(k) record lists Neurosigma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

The FDA product code for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is QGL.

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第2世代モナーク外用三叉神経刺激（eTNS）システム®

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：QGL）

公式ソース