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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K152043
Device Name Diagnostic Station DS20
Applicant
SCHILLER AG
ALTGASSE 68
baar,  CH ch-6341
Applicant Contact zhenrong yu
Correspondent
ZOE MEDICAL, INC.
460 BOSTON STREET
topsfield,  MA  01983
Correspondent Contact jim chickering
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/23/2015
Decision Date 05/06/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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