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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 K860636
Device Name FASTRACE III, ECG ELECTRODE
Applicant
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact NILAY K SANKALIA
Correspondent
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact NILAY K SANKALIA
Regulation Number870.2340
Classification Product Code
DPS  
Date Received02/21/1986
Decision Date 05/09/1986
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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