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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K232354
Device Name Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
Applicant
Murata Vios, Inc.
700 Commerce Dr., #190
Woodbury,  MN  55125
Applicant Contact Amit Patel
Correspondent
Murata Vios, Inc.
700 Commerce Dr., #190
Woodbury,  MN  55125
Correspondent Contact John Lansdown
Regulation Number870.2300
Classification Product Code
DRT  
Subsequent Product Codes
DPZ   DQA   DRG   DSI   DXJ  
MHX   OUG  
Date Received08/07/2023
Decision Date 03/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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