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FDA 510(k) Application Details - K250286
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Daniel Gregory
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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