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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 K914838
Device Name PROPAQ 102,104,106,102EL,104EL,&106EL
Applicant
Protocol Systems, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Applicant Contact LEE A.TAYLOR
Correspondent
Protocol Systems, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Correspondent Contact LEE A.TAYLOR
Regulation Number870.1025
Classification Product Code
MHX  
Date Received10/25/1991
Decision Date 01/10/1992
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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