FDA 510(k) Application Details - K052060

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K052060
Device Name	Amplifier, Physiological Signal
Applicant	INTELLIGENT HEARING SYSTEMS 7356 S.W. 48 ST. MIAMI, FL 33155 US Other 510(k) Applications for this Company
Contact	EDWARD MISKIEL Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2005
Decision Date	08/31/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review