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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K262816
Device Name EXG PulseLinQ Cables (EXGPL)
Applicant
Cb Innovations, LLC
5835 Avenida Encinas, Suite 118
Carlsbad,  CA  92008
Applicant Contact Oxana Pantchenko
Correspondent
Cb Innovations, LLC
5835 Avenida Encinas, Suite 118
Carlsbad,  CA  92008
Correspondent Contact Oxana Pantchenko
Regulation Number870.2900
Classification Product Code
DSA  
Date Received08/07/2026
Decision Date 10/30/2026
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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