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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.
813 D St., Suite 3
San Rafael,  CA  94901 -2813
Applicant Contact Kunj Patel
Correspondent
Safebeat Rx, Inc.
813 D St., Suite 3
San Rafael,  CA  94901 -2813
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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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