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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K992908
Device Name Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
Applicant
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact MATTHEW J HEDLUND
Correspondent
Quinton, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact MATTHEW J HEDLUND
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/30/1999
Decision Date 03/06/2000
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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