FDA 510(k) Application Details - K121197

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K121197
Device Name	Detector And Alarm, Arrhythmia
Applicant	PREVENTICE, INC. 2765 COMMERCE DRIVE NW SUITE 220 ROCHESTER, MN 55901 US Other 510(k) Applications for this Company
Contact	DREW PALIN Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	DSI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2012
Decision Date	08/10/2012
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