510(k) · Cardiovascular

Stethee Pro 1, Stethee Pro Software System

by M3DICINE Pty Ltd.

Stethee Pro 1, Stethee Pro Software System is an AI-enabled medical device from M3DICINE Pty Ltd. that the U.S. FDA cleared through 510(k) K193631 on October 9, 2020. Its lead review panel is Cardiovascular and its primary product code is DQD (Stethoscope, Electronic).

See also FDA-cleared AI cardiovascular devices in 2020, all FDA AI clearances in 2020, top cardiovascular AI devices.

Key facts

Submission numberK193631
Pathway510(k)
Date of final decision
Company (FDA list)M3DICINE Pty Ltd.
Lead review panelCardiovascular
Primary product codeDQD — Stethoscope, Electronic
Applicant (openFDA)M3Dicine Pty , Ltd.
Applicant locationEight Mile Plains, AU
Device classClass 2
Regulation number21 CFR 870.1875
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Stethee Pro 1, Stethee Pro Software System went through this pathway (K193631).

openFDA lists it as a Class 2 device under 21 CFR 870.1875. Class II devices are moderate risk and are subject to general and special controls.

Product code DQD covers 14 devices on the FDA AI list. By decision date, this device is #6 of 14 under that code. M3DICINE Pty Ltd. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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