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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K871363
Device Name MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE
Applicant
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact RANDY WALLS
Correspondent
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact RANDY WALLS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/07/1987
Decision Date 06/05/1987
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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