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FDA 510(k)

Electronic Stethoscope DS3011A

K-Number: K173663 · 2018-08-17

ApplicantImediplus, Inc.
Decision Date2018-08-17
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Stethoscope DS3011A is a medical device manufactured by Imediplus, Inc.. It received FDA 510(k) clearance on 2018-08-17 under approval number K173663. 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 Electronic Stethoscope DS3011A?

Electronic Stethoscope DS3011A is a medical device that received FDA 510(k) clearance on 2018-08-17. It is manufactured by Imediplus, Inc.. The 510(k) number is K173663.

When was Electronic Stethoscope DS3011A approved by the FDA?

Electronic Stethoscope DS3011A received FDA 510(k) clearance on 2018-08-17, under approval number K173663.

What company makes Electronic Stethoscope DS3011A?

Electronic Stethoscope DS3011A is manufactured by Imediplus, Inc..

What is the FDA product code for Electronic Stethoscope DS3011A?

The FDA product code for Electronic Stethoscope DS3011A is DQD.

Related Clinical Trials

NCT07568795 Clinical Validation of Portable Electronic Stethoscope for Detecting VHD RECRUITING NCT06734793 Wearable Electronic Breath Sound Sensing Device RECRUITING

Other Devices by Imediplus, Inc.

K160023Electronic Stethoscope DS301 K182196Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

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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