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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K192004
FOIA Releasable 510(k) K192004
Device Name Eko Analysis Software
Applicant
Eko Devices, Inc.
2600 10th St.
Suite 260
Berkeley,  CA  94710
Applicant Contact Connor Landgraf
Correspondent
Manatt, Phelps, & Phillips, Llp
One Embarcadero Center, 30th Floor
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DPS   DQD  
Date Received07/26/2019
Decision Date 01/15/2020
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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