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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 K945476
Device Name HEARTHWATCH III(TM)
Applicant
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Applicant Contact HERBERT J SEMLER
Correspondent
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Correspondent Contact HERBERT J SEMLER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received11/08/1994
Decision Date 11/09/1995
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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