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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 K251218
Device Name SafeBeat Rx App
Applicant
SafeBeat Rx, Inc.
450 Sutter St.
Suite 1530
San Francisco,  CA  94108
Applicant Contact Rachita Navara
Correspondent
SafeBeat Rx, Inc.
450 Sutter St.
Suite 1530
San Francisco,  CA  94108
Correspondent Contact Rachita Navara
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
DPS  
Date Received04/21/2025
Decision Date 02/06/2026
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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