FDA 510(k) Application Details - K192732

Device Classification Name	Detector And Alarm, Arrhythmia   More FDA Info for this Device
510(K) Number	K192732
Device Name	Detector And Alarm, Arrhythmia
Applicant	Preventice Technologies, Inc. 3052 Hwy52 N, Building 003-2 Rochester, MN 55901 US Other 510(k) Applications for this Company
Contact	Charles Rector 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	09/27/2019
Decision Date	03/26/2020
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