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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 K201742
Device Name eKuore One Wireless Electronic Interface for stethoscope
Applicant
Chip Ideas Electronics S.L.
Calle Alfareria 3 B
Burjasot,  ES 46100
Applicant Contact Bernardo Plaza Trillo
Correspondent
Chip Ideas Electronics S.L.
Calle Alfareria 3 B
Burjasot,  ES 46100
Correspondent Contact Bernardo Plaza Trillo
Regulation Number870.1875
Classification Product Code
DQD  
Date Received06/25/2020
Decision Date 11/24/2020
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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