FDA 510(k) Application Details - K101982

Device Classification Name	Tester, Pacemaker Electrode Function   More FDA Info for this Device
510(K) Number	K101982
Device Name	Tester, Pacemaker Electrode Function
Applicant	ST JUDE MEDICAL, CRMD 701 E. EVELYN AVENUE SUNNYVALE, CA 94086 US Other 510(k) Applications for this Company
Contact	Gina Correa Other 510(k) Applications for this Contact
Regulation Number	870.3720   More FDA Info for this Regulation Number
Classification Product Code	DTA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2010
Decision Date	12/21/2010
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