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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K253562
Device Name medilogFD
Applicant
Schiller AG
Altgasse 68
Baar,  CH CH-6341
Applicant Contact Stefan Bigler
Correspondent
Schiller AG
15 Belleau Woods
Georgetown,  MA  01833
Correspondent Contact Jim Chickering
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received11/17/2025
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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