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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K151139
Device Name EasyMap MAP Catheter
Applicant
Medfact Engineering GmbH
Hammerstr.3
Loerrach, Baden-Wurttemberg,  DE D-79540
Applicant Contact Joerg Reinhardt
Correspondent
Graematter, Inc.
1324 Clarkson Clayton Ctr
#332
Ballwin,  MO  63011
Correspondent Contact Melissa Walker
Regulation Number870.1220
Classification Product Code
DRF  
Date Received04/29/2015
Decision Date 10/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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