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FDA 510(k)

Stethee Pro

K-Number: K172296 · 2017-10-30

ApplicantM3Dicine Pty , Ltd.
Decision Date2017-10-30
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stethee Pro is a medical device manufactured by M3Dicine Pty , Ltd.. It received FDA 510(k) clearance on 2017-10-30 under approval number K172296. 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 Stethee Pro?

Stethee Pro is a medical device that received FDA 510(k) clearance on 2017-10-30. It is manufactured by M3Dicine Pty , Ltd.. The 510(k) number is K172296.

When was Stethee Pro approved by the FDA?

Stethee Pro received FDA 510(k) clearance on 2017-10-30, under approval number K172296.

What company makes Stethee Pro?

Stethee Pro is manufactured by M3Dicine Pty , Ltd..

What is the FDA product code for Stethee Pro?

The FDA product code for Stethee Pro is DQD.

Other Devices by M3Dicine Pty , Ltd.

K193631Stethee Pro 1, Stethee Pro Software System

Related Devices (Code: DQD)

K160401Tyto StethoscopeTyto Care , Ltd. K160023Electronic Stethoscope DS301Imediplus, Inc. K160016Steth IOStratoscientific, Inc. K170928CADence SystemAum Cardiovascular, Inc. K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. K162589Adscope 658 Electronic StethoscopeAmerican Diagnostic Corp.

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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