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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name detector and alarm, arrhythmia
510(k) Number K153477
Device Name EMMa Electronic Monitoring Management
Applicant
VITASYSTEMS GMBH
MARKIRCHER STR. 22
Mannheim,  DE 68229
Applicant Contact Michael Rothhaar
Correspondent
VITASYSTEMS GMBH
MARKIRCHER STR. 22
Mannheim,  DE 68229
Correspondent Contact Michael Rothhaar
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/02/2015
Decision Date 05/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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