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FDA 510(k)

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

K-Number: K182196 · 2018-09-11

ApplicantImediplus, Inc.
Decision Date2018-09-11
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is a medical device manufactured by Imediplus, Inc.. It received FDA 510(k) clearance on 2018-09-11 under approval number K182196. 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 Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is a medical device that received FDA 510(k) clearance on 2018-09-11. It is manufactured by Imediplus, Inc.. The 510(k) number is K182196.

When was Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth approved by the FDA?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth received FDA 510(k) clearance on 2018-09-11, under approval number K182196.

What company makes Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is manufactured by Imediplus, Inc..

What is the FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

The FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is DQD.

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Other Devices by Imediplus, Inc.

K160023Electronic Stethoscope DS301 K173663Electronic Stethoscope DS3011A

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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