FDA 510(k) Application Details - K150005

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K150005
Device Name	Stimulator, Nerve
Applicant	NDI Medical, LLC 22901 Millcreek Boulevard, Suite 110 Cleveland, OH 44122 US Other 510(k) Applications for this Company
Contact	Robert Rogers Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2015
Decision Date	02/19/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review