FDA 510(k) Application Details - K150992

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K150992
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	VIOS MEDICAL, INC. 7300 HUDSON BLVD N, STE 140 ST. PAUL, MN 55128 US Other 510(k) Applications for this Company
Contact	MEGAN GRAHAM 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	04/15/2015
Decision Date	12/16/2015
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