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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K010396
Device Name C. NET 2100
Applicant
Cardionetics, Ltd.
195 W. St.
Waltham,  MA  02451
Applicant Contact BARRY SALL
Correspondent
Cardionetics, Ltd.
195 W. St.
Waltham,  MA  02451
Correspondent Contact BARRY SALL
Regulation Number870.2800
Classification Product Code
MLO  
Date Received02/09/2001
Decision Date 10/04/2001
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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