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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 K191620
Device Name Vitls Platform
Applicant
Vitls, Inc.
Tmc Innovation Institute, Suite X, 2450 Holcombe Blvd.
Houston,  TX  77021
Applicant Contact Werner Vorster
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Code
FLL  
Date Received06/18/2019
Decision Date 06/01/2020
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
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