ES001 Digital Stethoscope For General-purpose Auscultation, ES002 Digital Stethoscope For Hearing Impaired Users, ES003 Digital Stethoscope For Telemedicine.

Stethoscope, Electronic

Chip Ideas Electronics S.L.

The following data is part of a premarket notification filed by Chip Ideas Electronics S.l. with the FDA for Es001 Digital Stethoscope For General-purpose Auscultation, Es002 Digital Stethoscope For Hearing Impaired Users, Es003 Digital Stethoscope For Telemedicine..

Pre-market Notification Details

Device IDK211779
510k NumberK211779
Device Name:ES001 Digital Stethoscope For General-purpose Auscultation, ES002 Digital Stethoscope For Hearing Impaired Users, ES003 Digital Stethoscope For Telemedicine.
ClassificationStethoscope, Electronic
Applicant Chip Ideas Electronics S.L. Calle Alfareria 3 B Burjasot,  ES 46100
ContactBernardo Plaza Trillo
CorrespondentBernardo Plaza Trillo
Chip Ideas Electronics S.L. Calle Alfareria 3 B Burjasot,  ES 46100
Product CodeDQD  
CFR Regulation Number870.1875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-09
Decision Date2022-05-26

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