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FDA 510(k)

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

K-Number: K211779 · 2022-05-26

ApplicantChip Ideas Electronics S.L.
Decision Date2022-05-26
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. is a medical device manufactured by Chip Ideas Electronics S.L.. It received FDA 510(k) clearance on 2022-05-26 under approval number K211779. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.?

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. is a medical device that received FDA 510(k) clearance on 2022-05-26. It is manufactured by Chip Ideas Electronics S.L.. The 510(k) number is K211779.

When was ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. approved by the FDA?

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. received FDA 510(k) clearance on 2022-05-26, under approval number K211779.

What company makes ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.?

ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. is manufactured by Chip Ideas Electronics S.L..

What is the FDA product code for ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.?

The FDA product code for ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. is DQD.

Related Clinical Trials

NCT07572357 Clinical Evaluation of the RH210 Hearing Aid RECRUITING NCT07613502 Bio Leg: Advancing Mobility NOT_YET_RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613268 Exploratory Trial of the "HiDongDong" Language Rehabilitation App for Articulation Delay. NOT_YET_RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42145202 Fertile-window misclassification in period-tracking applications and associated pregnancy risk: a large observational analysis. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (2026) PMID: 42144441 A workflow utilizing general-purpose large language models for efficient structuring and data mining of bone scintigraphy narratives. Scientific reports (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 39950674 Contemporary Landscape of Medical Technology in Gastroenterology Between 2013 and 2023. The American journal of gastroenterology (2025)

Other Devices by Chip Ideas Electronics S.L.

K181882eKuore One electronic interface for stethoscope K201742eKuore One Wireless Electronic Interface for stethoscope K203007eKuore Pro Series K212013eKuore Pro 4T - REF EP0098

Related Devices (Code: DQD)

K160401Tyto StethoscopeTyto Care , Ltd. K160023Electronic Stethoscope DS301Imediplus, Inc. K160016Steth IOStratoscientific, Inc. K172296Stethee ProM3Dicine Pty , Ltd. K170928CADence SystemAum Cardiovascular, Inc. K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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