FDA 510(k) Application Details - K990356

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K990356
Device Name	Device, Biofeedback
Applicant	DELSYS, INC. PO BOX 15734 BOSTON, MA 02215 US Other 510(k) Applications for this Company
Contact	GIANLUCA DE LUCA Other 510(k) Applications for this Contact
Regulation Number	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/1999
Decision Date	04/29/1999
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