FDA 510(k) Application Details - K002104

Device Classification Name	Electromyograph, Diagnostic   More FDA Info for this Device
510(K) Number	K002104
Device Name	Electromyograph, Diagnostic
Applicant	MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF 7481 W. OAKLAND PARK BLVD. # 305 FT. LAUDERDALE, FL 33319 US Other 510(k) Applications for this Company
Contact	MARYROSE CUSIMANO Other 510(k) Applications for this Contact
Regulation Number	890.1375   More FDA Info for this Regulation Number
Classification Product Code	IKN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2000
Decision Date	10/10/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review