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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K193343
Device Name Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
Applicant
Vitalconnect, Inc.
224 Airport Pkwy., Suite 300
San Jose,  CA  95110
Applicant Contact Cynthia Merrell
Correspondent
Vitalconnect, Inc.
224 Airport Pkwy., Suite 300
San Jose,  CA  95110
Correspondent Contact Cynthia Merrell
Regulation Number870.2910
Classification Product Code
DRG  
Date Received12/03/2019
Decision Date 04/20/2020
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
Recalls CDRH Recalls
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