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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 K950003
Device Name CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS
Applicant
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124 -5898
Applicant Contact HERBERT J SEMLER
Correspondent
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124 -5898
Correspondent Contact HERBERT J SEMLER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received01/03/1995
Decision Date 10/31/1995
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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