FDA 510(k) Application Details - K230014

Device Classification Name

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510(K) Number K230014
Device Name MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Applicant Tonica Elektronik A/S
Lucernemarken 15
Farum DK-3520 DK
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Contact Jan Kj°ller
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Regulation Number

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Classification Product Code QPL
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Date Received 01/03/2023
Decision Date 08/25/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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