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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 K942586
Device Name CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)
Applicant
Telescan Medical Systems
26424 Table Meadow Rd.
Auburn,  CA  95062
Applicant Contact STANLEY WEGNER
Correspondent
Telescan Medical Systems
26424 Table Meadow Rd.
Auburn,  CA  95062
Correspondent Contact STANLEY WEGNER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/12/1994
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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