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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 K032038
Device Name PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
Applicant
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021 -8906
Applicant Contact KAREN BROWNE
Correspondent
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021 -8906
Correspondent Contact KAREN BROWNE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/01/2003
Decision Date 09/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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