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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 K130785
Device Name SEER 1000
Applicant
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
oderstrasse 77
teltow,  DE 14513
Applicant Contact bert schadow
Correspondent
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
oderstrasse 77
teltow,  DE 14513
Correspondent Contact bert schadow
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received03/21/2013
Decision Date 07/26/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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