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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K913193
Device Name MODEL 100 CENTRAL STATION
Applicant
Protocol Systems, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Applicant Contact JAMES W SANDBERT
Correspondent
Protocol Systems, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Correspondent Contact JAMES W SANDBERT
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/18/1991
Decision Date 10/16/1991
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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