FDA 510(k) Application Details - K071661

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K071661
Device Name	Device, Biofeedback
Applicant	TELEDIAGNOSTIC SYSTEMS, INC. 2484 OLD MIDDLEFIELD WAY SUITE 202 MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	LARRY WOODWARD 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	06/19/2007
Decision Date	09/05/2007
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