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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K193631
Device Name Stethee Pro 1, Stethee Pro Software System
Applicant
M3Dicine Pty , Ltd.
Level 1, 88 Brandl St.
Eight Mile Plains,  AU 4113
Applicant Contact Nayyar Hussain
Correspondent
Centaur Consulting, LLC
W9281 710th Ave.
River Falls,  WI  54022
Correspondent Contact Ginger Cantor
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Codes
BZQ   DQC   DRG  
Date Received12/27/2019
Decision Date 10/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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