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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K992703
Device Name CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
Applicant
Premier Heart, LLC
601 13th St., NW
Suite 901 S.
Washington,  DC  20005
Applicant Contact WILLIAM D HARE
Correspondent
Premier Heart, LLC
601 13th St., NW
Suite 901 S.
Washington,  DC  20005
Correspondent Contact WILLIAM D HARE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/12/1999
Decision Date 03/21/2000
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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