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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K172801
Device Name ECG SENTINEL System
Applicant
Cardiomedix, Inc.
1840 Oak Ave.
evanston,  IL  60201
Applicant Contact zipora david
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25TH STREET, NW
buffalo,  MN  55313
Correspondent Contact mark job
Regulation Number870.2920
Classification Product Code
DXH  
Date Received09/18/2017
Decision Date 10/18/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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