FDA 510(k) Application Details - K203684

Device Classification Name	More FDA Info for this Device
510(K) Number	K203684
Device Name	Neurosign V4 Intraoperative Nerve Monitor
Applicant	Magstim Company Ltd. Spring Gardens Whitland SA34 0HR GB Other 510(k) Applications for this Company
Contact	Rosie Hunt Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2020
Decision Date	03/17/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review