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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 K934711
Device Name PROPAQ ECG TELEMETRY OPTION
Applicant
Protocol Systems, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Applicant Contact JAMES P WELCH
Correspondent
Protocol Systems, Inc.
8500 SW Creekside Pl.
Beaverton,  OR  97008
Correspondent Contact JAMES P WELCH
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/01/1993
Decision Date 09/01/1994
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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