FDA 510(k)

Electronic Stethoscope DS301

K-Number: K160023 · 2016-09-30

Decision Date2016-09-30

Product CodeDQD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Electronic Stethoscope DS301 is a medical device manufactured by Imediplus, Inc.. It received FDA 510(k) clearance on 2016-09-30 under approval number K160023. 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 DS301?

Electronic Stethoscope DS301 is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by Imediplus, Inc.. The 510(k) number is K160023.

When was Electronic Stethoscope DS301 approved by the FDA?

Electronic Stethoscope DS301 received FDA 510(k) clearance on 2016-09-30, under approval number K160023.

What company makes Electronic Stethoscope DS301?

Electronic Stethoscope DS301 is manufactured by Imediplus, Inc..

What is the FDA product code for Electronic Stethoscope DS301?

The FDA product code for Electronic Stethoscope DS301 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.

K182196Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth K173663Electronic Stethoscope DS3011A

Related Devices (Code: DQD)

K160401Tyto StethoscopeTyto Care , Ltd. K160016Steth IOStratoscientific, Inc. K172296Stethee ProM3Dicine Pty , Ltd. K170928CADence SystemAum Cardiovascular, Inc. K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. K162589Adscope 658 Electronic StethoscopeAmerican Diagnostic Corp.

Official Source

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