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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K002725
Device Name MICROPAQ, MODELS 402 AND 404
Applicant
Protocol Systems, Inc.
8500 SW Creekside Place
Beaverton,  OR  97008 -7101
Applicant Contact DON M ABBEY
Correspondent
Protocol Systems, Inc.
8500 SW Creekside Place
Beaverton,  OR  97008 -7101
Correspondent Contact DON M ABBEY
Regulation Number870.2300
Classification Product Code
DRT  
Date Received08/31/2000
Decision Date 11/21/2000
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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