Stethee Pro 1, Stethee Pro Software System

Stethoscope, Electronic

M3DICINE Pty Ltd.

The following data is part of a premarket notification filed by M3dicine Pty Ltd. with the FDA for Stethee Pro 1, Stethee Pro Software System.

Pre-market Notification Details

Device IDK193631
510k NumberK193631
Device Name:Stethee Pro 1, Stethee Pro Software System
ClassificationStethoscope, Electronic
Applicant M3DICINE Pty Ltd. Level 1, 88 Brandl Street Eight Mile Plains,  AU 4113
ContactNayyar Hussain
CorrespondentGinger Cantor
Centaur Consulting LLC W9281 710th Avenue River Falls,  WI  54022
Product CodeDQD  
Subsequent Product CodeDQC
Subsequent Product CodeDRG
CFR Regulation Number870.1875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-27
Decision Date2020-10-09

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