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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, programmable
510(k) Number K183266
Device Name EP-TRACER System
Schwarzer CardioTek GmbH
Im Zukunftspark 3
heilbronn,  DE 74076
Applicant Contact tatjana nuber
Graematter, Inc.
1324 Clarkson Clayton Ctr, #332
ballwin,  MO  63011
Correspondent Contact melissa walker
Regulation Number870.1425
Classification Product Code
Date Received11/23/2018
Decision Date 03/01/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No