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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
Recalls CDRH Recalls
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