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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 K981697
Device Name CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM
Applicant
Cambridge Heart, Inc.
1 Oak Park Dr.
Bedford,  MA  01730
Applicant Contact JOHN D GREENBAUM
Correspondent
Cambridge Heart, Inc.
1 Oak Park Dr.
Bedford,  MA  01730
Correspondent Contact JOHN D GREENBAUM
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/11/1998
Decision Date 10/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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