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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 K001492
Device Name QUINTON Q-STRESS, MODEL 000483
Applicant
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact DAVID HIMES
Correspondent
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact DAVID HIMES
Regulation Number870.2340
Classification Product Code
DPS  
Date Received05/12/2000
Decision Date 08/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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