Stethee Pro— 510(k) K172296

Substantially Equivalent

M3Dicine Pty , Ltd.

FDA 510(k) clearance K172296 for Stethee Pro, Substantially Equivalent on 2017-10-30. 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: 2017-07-31
Decision date: 2017-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, 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.