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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K851302
Device Name QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
Applicant
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Applicant Contact DAN ROPER
Correspondent
QUINTON, INC.
2121 TERRY AVE.
SEATLE,  WA  98121
Correspondent Contact DAN ROPER
Regulation Number870.2910
Classification Product Code
DRG  
Date Received04/01/1985
Decision Date 05/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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