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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 K201298
Device Name VX1
Volta Medical
29 Boulevard de Louvain
Marseille,  FR 13008
Applicant Contact Théophile Mohr Durdez
Hogan Lovells US LLP
1735 Market Street, Suite 2300
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number870.1425
Classification Product Code
Date Received05/15/2020
Decision Date 09/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No