FDA 510(k) Application Details - K982103

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K982103
Device Name	Nystagmograph
Applicant	SYNAPSYS, INC. 1400 MAIN ST. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	VERA BUFFALOE Other 510(k) Applications for this Contact
Regulation Number	882.1460   More FDA Info for this Regulation Number
Classification Product Code	GWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/1998
Decision Date	09/11/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review