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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K200313
Device Name VIVO
Applicant
Catheter Precision, Inc.
500 International Drive, Suite 255
Mt. Olive,  NJ  07828
Applicant Contact Steve Adler
Correspondent
Catheter Precision, Inc.
500 International Drive, Suite 255
Mt. Olive,  NJ  07828
Correspondent Contact Steve Adler
Regulation Number870.1425
Classification Product Code
DQK  
Date Received02/06/2020
Decision Date 09/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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