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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 K223812
Device Name Sensis Vibe (VD15)
Applicant
Siemens Medical Solutions USA Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Patricia D Jones
Correspondent
Siemens Medical Solutions USA Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Patricia D Jones
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
CCK   DQA   DRQ   DSJ   DSK  
DXN   FLL   KRB  
Date Received12/20/2022
Decision Date 09/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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