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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 K242129
Device Name VitalRhythm
Applicant
Vitalconnect, Inc.
2870 Zanker Rd.
Suite 100
San Jose,  CA  95134
Applicant Contact Gabriel Nallathambi
Correspondent
Vitalconnect, Inc.
2870 Zanker Rd.
Suite 100
San Jose,  CA  95134
Correspondent Contact Gabriel Nallathambi
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DPS   QYX  
Date Received07/22/2024
Decision Date 04/17/2025
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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