FDA 510(k) Application Details - K101867

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K101867
Device Name	Electrocardiograph
Applicant	VICOR TECHNOLOGIES, INC. 261 MADISON AVE. 24TH FLOOR NEW YORK, NY 10016 US Other 510(k) Applications for this Company
Contact	GLEN PARK Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2010
Decision Date	04/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review