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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K950018
Device Name CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM
Applicant
Cambridge Heart, Inc.
One Oak Park Dr.
Bedford,  MA  01730
Applicant Contact M ARIE
Correspondent
Cambridge Heart, Inc.
One Oak Park Dr.
Bedford,  MA  01730
Correspondent Contact M ARIE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/03/1995
Decision Date 02/29/1996
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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