FDA 510(k) Application Details - K182542

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K182542
Device Name	Stimulator, Electrical, Evoked Response
Applicant	SafeOp Surgical, Inc. 11350 McCormick Rd, Suite 1003 Hunt Valley, MD 21031 US Other 510(k) Applications for this Company
Contact	Richard O'Brien Other 510(k) Applications for this Contact
Regulation Number	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2018
Decision Date	02/22/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review