FDA 510(k) Application Details - K140086

Device Classification Name	Transducer, Tremor   More FDA Info for this Device
510(K) Number	K140086
Device Name	Transducer, Tremor
Applicant	GKC MANUFACTURING PTY LTD. 1801 ROCKVILLE PIKE SUITE 300 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	MARIE SCHROEDER Other 510(k) Applications for this Contact
Regulation Number	882.1950   More FDA Info for this Regulation Number
Classification Product Code	GYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/14/2014
Decision Date	08/22/2014
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