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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 K170874
Device Name Eko Model E5 System (EME5), Eko DUO
Applicant
Eko Devices, Inc.
2600 10th St, Suite 260
Berkeley,  CA  94710
Applicant Contact Connor Landgraf
Correspondent
Righter Consulting Group, LLC
PO Box 63
Tolovana Park,  OR  97145
Correspondent Contact Michael Righter
Regulation Number870.1875
Classification Product Code
DQD  
Subsequent Product Code
DPS  
Date Received03/24/2017
Decision Date 05/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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