FDA 510(k) Application Details - K123916

Device Classification Name	Pulse-Generator, Pacemaker, External   More FDA Info for this Device
510(K) Number	K123916
Device Name	Pulse-Generator, Pacemaker, External
Applicant	OSYPKA MEDICAL, INC. 7855 IVANHOE AVE., SUITE 226 LA JOLLA, CA 92037 US Other 510(k) Applications for this Company
Contact	MARKUS OSYPKA Other 510(k) Applications for this Contact
Regulation Number	870.3600   More FDA Info for this Regulation Number
Classification Product Code	DTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2012
Decision Date	04/09/2013
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review