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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 K924187
Device Name INSTANT MEMORY 2000
Applicant
TELESCAN MEDICAL SYSTEMS
10091 STREETER RD.
AUBURN,  CA  95003
Applicant Contact STANLEY WAGNER
Correspondent
TELESCAN MEDICAL SYSTEMS
10091 STREETER RD.
AUBURN,  CA  95003
Correspondent Contact STANLEY WAGNER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/20/1992
Decision Date 06/16/1993
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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