FDA 510(k) Application Details - K972515

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K972515
Device Name	Amplifier, Physiological Signal
Applicant	PRO-TECH SERVICES, INC. 12826 N.W. 178TH ST., SUITE A P.O. BOX 2165 WOODINVILLE, WA 98072 US Other 510(k) Applications for this Company
Contact	ANTHONY ZARAGOZA 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	07/03/1997
Decision Date	10/02/1997
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