FDA 510(k) Application Details - K232354

Device Classification Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)   More FDA Info for this Device
510(K) Number	K232354
Device Name	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant	Murata Vios, Inc. 700 Commerce Drive, #190 Woodbury, MN 55125 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	08/07/2023
Decision Date	03/22/2024
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