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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K041607
Device Name QUINTON Q-TE; RMS
Applicant
Quinton Cardiology, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact KAREN BROWNE
Correspondent
Quinton Cardiology, Inc.
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact KAREN BROWNE
Regulation Number870.1025
Classification Product Code
MHX  
Date Received06/15/2004
Decision Date 07/16/2004
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
Recalls CDRH Recalls
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