FDA 510(k) Application Details - K974385

Device Classification Name	Electromyograph, Diagnostic   More FDA Info for this Device
510(K) Number	K974385
Device Name	Electromyograph, Diagnostic
Applicant	MOTION LAB SYSTEMS, INC. 4326 PINE PARK DR. BATON ROUGE, LA 70809-2397 US Other 510(k) Applications for this Company
Contact	EDMUND CRAMP 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	11/21/1997
Decision Date	02/19/1998
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