FDA 510(k) Application Details - K250286

Device Classification Name

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510(K) Number K250286
Device Name Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
Applicant The Magstim Company Limited
Spring Gardens
Whitland
Carmarthenshire SA34 0HR GB
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Contact Daniel Gregory
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Regulation Number

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Classification Product Code QPL
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Date Received 01/31/2025
Decision Date 07/03/2025
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

FDA Source Information for K250286


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