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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K252076
Device Name Kneevoice Cartilage Evaluation System (750-3600-001)
Applicant
Kneevoice, Inc.
1626 Montana Ave.
Santa Monica,  CA  90403
Applicant Contact Gustavo DeGreiff
Correspondent
Kneevoice, Inc.
1626 Montana Ave.
Santa Monica,  CA  90403
Correspondent Contact Marianne Grunwaldt
Regulation Number870.1875
Classification Product Code
DQD  
Date Received07/02/2025
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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