Stethee Pro 1, Stethee Pro Software System— 510(k) K193631

Name: FDA 510(k) clearance K193631
Creator: U.S. Food and Drug Administration
Published: 2020-10-09

Substantially Equivalent

M3Dicine Pty , Ltd.

FDA 510(k) clearance K193631 for Stethee Pro 1, Stethee Pro Software System, Substantially Equivalent on 2020-10-09. Applicant: M3Dicine Pty , Ltd.. Device class: 2.

Clearance details

Applicant: M3Dicine Pty , Ltd.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2019-12-27
Decision date: 2020-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eight Mile Plains, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.