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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K050951
Device Name MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370
Applicant
CIBERNET SYSTEMS CORP.
727 AIRPORT BOULEVARD
ANN ARBOR,  MI  48108
Applicant Contact ERIC LICHTENSTEIN
Correspondent
CIBERNET SYSTEMS CORP.
727 AIRPORT BOULEVARD
ANN ARBOR,  MI  48108
Correspondent Contact ERIC LICHTENSTEIN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received04/15/2005
Decision Date 07/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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