FDA 510(k) Application Details - K110048

Device Classification Name	Electromyograph, Diagnostic   More FDA Info for this Device
510(K) Number	K110048
Device Name	Electromyograph, Diagnostic
Applicant	SPINEMATRIX, INC. 1835 MARKET STREET 29TH FLOOR PHILADELPHIA, PA 19103 US Other 510(k) Applications for this Company
Contact	JANICE M HOGAN 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	01/06/2011
Decision Date	01/26/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review