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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 K170182
Device Name CARDIOVIT FT-1
Applicant
SCHILLER AG
ALTGASSE 68
BAAR,  CH CH-6371
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 Received01/23/2017
Decision Date 07/19/2017
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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