FDA 510(k) Application Details - K973537

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K973537
Device Name	Device, Biofeedback
Applicant	THE PROMETHEUS GROUP 2 MALLARDS COVE DUXBURY, MA 02332 US Other 510(k) Applications for this Company
Contact	PETER A SULLIVAN 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	09/18/1997
Decision Date	12/17/1997
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