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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 K943931
Device Name CARRYALL ENHANCEMENTS
Applicant
Instromedix, Inc.
7431 NE Evergreen Pkwy.,
One Technology Center
Hillsboro,  OR  97124
Applicant Contact HERBERT J SEMLER
Correspondent
Instromedix, Inc.
7431 NE Evergreen Pkwy.,
One Technology Center
Hillsboro,  OR  97124
Correspondent Contact HERBERT J SEMLER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/12/1994
Decision Date 04/04/1995
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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