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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 K151319
Device Name Eko Electronic Stethoscope System
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  
Date Received05/18/2015
Decision Date 08/28/2015
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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