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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 K020534
Device Name MEDSTAR SYSTEM, MODELS 533-300
Applicant
Cybernet Medical
727 Airport Blvd.
Ann Arbor,  MI  48108
Applicant Contact DAVID A.C. GREEN
Correspondent
Cybernet Medical
727 Airport Blvd.
Ann Arbor,  MI  48108
Correspondent Contact DAVID A.C. GREEN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received02/19/2002
Decision Date 02/11/2003
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
Recalls CDRH Recalls
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