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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 K082312
Device Name PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
Applicant
Heartscape Technologies, Ltd.
Unit 1, 6b Balloo Dr.
Bangor, Co Down,  GB BT19 7QY
Applicant Contact PAUL PHILLIPS
Correspondent
Heartscape Technologies, Ltd.
Unit 1, 6b Balloo Dr.
Bangor, Co Down,  GB BT19 7QY
Correspondent Contact PAUL PHILLIPS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/13/2008
Decision Date 09/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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