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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K261580
Device Name ZBPro Diagnostic (Version 2.0)
Applicant
Zbeats, Inc.
25 Health Sciences Dr.
Stony Brook,  NY  11790
Applicant Contact Bin Fang
Correspondent
Zaliance Medical Solutions, LLC
5153 W. Wooley Rd.
Oxnard,  CA  93035
Correspondent Contact Christopher Ford
Regulation Number870.2800
Classification Product Code
MLO  
Date Received05/13/2026
Decision Date 09/11/2026
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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