FDA 510(k) Application Details - K050991

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K050991
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. ONE CHAGRIN HIGHLANDS 2000 AUBURN DRIVE, SUITE 320 CLEVELAND, OH 44122 US Other 510(k) Applications for this Company
Contact	TINA LECHMAN Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2005
Decision Date	07/15/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review