FDA 510(k) Application Details - K172586

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K172586
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	Vios Medical, Inc. 7300 Hudson Blvd N St. Paul, MN 55128 US Other 510(k) Applications for this Company
Contact	Amit Patel Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	DRT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2017
Decision Date	06/22/2018
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