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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 K232616
Device Name Volta AF-Xplorer
Applicant
Volta Medical
65 Avenue Jules Cantini
Marseille,  FR 13006
Applicant Contact Paola Milpied
Correspondent
Hogan Lovells US LPP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact Kristin Zielinski Duggan
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/28/2023
Decision Date 09/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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