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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 K211779
Device Name ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
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 Received06/09/2021
Decision Date 05/26/2022
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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