FDA 510(k) Application Details - K991642

Device Classification Name	Nystagmograph   More FDA Info for this Device
510(K) Number	K991642
Device Name	Nystagmograph
Applicant	BERTEC CORP. 6185 HUNTLEY RD., SUITE B COLUMBUS, OH 43229 US Other 510(k) Applications for this Company
Contact	DOUG MORR 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	05/13/1999
Decision Date	08/03/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review