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FDA 510(k)

eKuore One Wireless Electronic Interface for stethoscope

K-Number: K201742 · 2020-11-24

ApplicantChip Ideas Electronics S.L.
Decision Date2020-11-24
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

eKuore One Wireless Electronic Interface for stethoscope is a medical device manufactured by Chip Ideas Electronics S.L.. It received FDA 510(k) clearance on 2020-11-24 under approval number K201742. 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 eKuore One Wireless Electronic Interface for stethoscope?

eKuore One Wireless Electronic Interface for stethoscope is a medical device that received FDA 510(k) clearance on 2020-11-24. It is manufactured by Chip Ideas Electronics S.L.. The 510(k) number is K201742.

When was eKuore One Wireless Electronic Interface for stethoscope approved by the FDA?

eKuore One Wireless Electronic Interface for stethoscope received FDA 510(k) clearance on 2020-11-24, under approval number K201742.

What company makes eKuore One Wireless Electronic Interface for stethoscope?

eKuore One Wireless Electronic Interface for stethoscope is manufactured by Chip Ideas Electronics S.L..

What is the FDA product code for eKuore One Wireless Electronic Interface for stethoscope?

The FDA product code for eKuore One Wireless Electronic Interface for stethoscope is DQD.

Related Clinical Trials

NCT07608614 Sleep and Performance RECRUITING NCT07603752 Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study RECRUITING NCT07568795 Clinical Validation of Portable Electronic Stethoscope for Detecting VHD RECRUITING NCT06734793 Wearable Electronic Breath Sound Sensing Device RECRUITING

Other Devices by Chip Ideas Electronics S.L.

K181882eKuore One electronic interface for stethoscope K203007eKuore Pro Series K212013eKuore Pro 4T - REF EP0098 K211779ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

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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