FDA 510(k) Application Details - K130806

Device Classification Name	More FDA Info for this Device
510(K) Number	K130806
Device Name	NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
Applicant	NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE, SUITE 1000 VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	CHRISTINE VERGELY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2013
Decision Date	07/12/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review