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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 K172296
Device Name Stethee Pro
Applicant
M3Dicine Pty , Ltd.
1389 Beenleigh Rd.
Brisbane,  AU 4112
Applicant Contact Nayyar Hussain
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1875
Classification Product Code
DQD  
Date Received07/31/2017
Decision Date 10/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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