FDA 510(k) Application Details - K980866

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K980866
Device Name	Stimulator, Electrical, Evoked Response
Applicant	NEURO-DIAGNOSTIC ASSOC. 445 DARTMOOR ST. LAGUNA BEACH, CA 92651 US Other 510(k) Applications for this Company
Contact	JAMES L HEDGECOCK, DC, PHD 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	02/19/1998
Decision Date	05/20/1998
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