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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 K252915
Device Name AiSteth®
Applicant
Ai Health Highway India Pvt., Ltd.
Dsi Innovation Campus, Block A, 2nd Floor Gharebhavipalya
Hongasandra Village, Hosur Rd.
Bangalore,  IN 560068
Applicant Contact Satish S. Jeevannavar
Correspondent
Ai Health Highway India Pvt., Ltd.
Dsi Innovation Campus, Block A, 2nd Floor Gharebhavipalya
Hongasandra Village, Hosur Rd.
Bangalore,  IN 560068
Correspondent Contact Satish S. Jeevannavar
Regulation Number870.1875
Classification Product Code
DQD  
Date Received09/12/2025
Decision Date 05/22/2026
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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