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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 K003576
Device Name Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
Applicant
QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021 -8906
Applicant Contact DAVID HIMES
Correspondent
QUINTON, INC.
3303 MONTE VILLA PKWY.
BOTHELL,  WA  98021 -8906
Correspondent Contact DAVID HIMES
Regulation Number870.1025
Classification Product Code
DSI  
Date Received11/20/2000
Decision Date 01/25/2001
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
Recalls CDRH Recalls
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