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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 K223516
Device Name VX1+
Volta Medical
65 Avenue Jules Cantini
Marseille,  FR 13006
Applicant Contact Paola Milpied
Hogan Lovells US LLP
555 13 Street NW
Washington,  DC  20004
Correspondent Contact Kristin Zielinski Duggan
Regulation Number870.1425
Classification Product Code
Date Received11/22/2022
Decision Date 01/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No