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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
Applicant
Volta Medical
29 Blvd. De Louvain
Marseille,  FR 13008
Applicant Contact Théophile Mohr Durdez
Correspondent
Hogan Lovells US LLP
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number870.1425
Classification Product Code
DQK  
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
Predetermined Change
Control Plan Authorized		 No
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