FDA 510(k) Application Details - K943535

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K943535
Device Name	Device, Biofeedback
Applicant	REGULATORY STRATEGIES, INC. 1660 RIVERTON POINT EAGAN, MN 55122 US Other 510(k) Applications for this Company
Contact	GREGORY J MATHISON 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	07/21/1994
Decision Date	06/25/1997
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