FDA 510(k) Application Details - K151600

Device Classification Name	Amplifier, Physiological Signal   More FDA Info for this Device
510(K) Number	K151600
Device Name	Amplifier, Physiological Signal
Applicant	LIFELINES LTD. 7 CLARENDON COURT OVER WALLOP SO20 8HU GB Other 510(k) Applications for this Company
Contact	Michael Hulin Other 510(k) Applications for this Contact
Regulation Number	882.1835   More FDA Info for this Regulation Number
Classification Product Code	GWL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/12/2015
Decision Date	10/23/2015
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