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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 K945626
Device Name QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
Applicant
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact JEROME J FREUNDLICH
Correspondent
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact JEROME J FREUNDLICH
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/16/1994
Decision Date 06/28/1995
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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