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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 K183425
Device Name CARDIOVIT AT-102 G2
Schiller AG
Altgasse 68
baar zug,  CH 6341
Applicant Contact sabina standiford
Arazy Group Consultants Inc.
68 Southwood Terrace
southbury,  CT  06488
Correspondent Contact ray kelly
Regulation Number870.2340
Classification Product Code
Date Received12/11/2018
Decision Date 03/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No