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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 K121825
Device Name CS-MAG II
Applicant
BIOMAGNETIK-PARK GMBH
BEIM STROHHAUSE 27
HAMBURG,  DE 20097
Applicant Contact THOMAS WEBER
Correspondent
BIOMAGNETIK-PARK GMBH
BEIM STROHHAUSE 27
HAMBURG,  DE 20097
Correspondent Contact THOMAS WEBER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/21/2012
Decision Date 03/11/2013
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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