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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 K864504
Device Name Q5000 STRESS TEST MONITOR
Applicant
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Applicant Contact RON R DUCK
Correspondent
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Correspondent Contact RON R DUCK
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/14/1986
Decision Date 04/09/1987
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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