ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.— 510(k) K211779

Name: FDA 510(k) clearance K211779
Creator: U.S. Food and Drug Administration
Published: 2022-05-26

Substantially Equivalent

Chip Ideas Electronics S.L.

FDA 510(k) clearance K211779 for ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine., Substantially Equivalent on 2022-05-26. Applicant: Chip Ideas Electronics S.L.. Device class: 2.

Clearance details

Applicant: Chip Ideas Electronics S.L.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2021-06-09
Decision date: 2022-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burjasot, ES

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.