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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 K910882
Device Name PROPAQ 102EL, 104EL AND 106EL
Applicant
Protocol Systems, Inc.
14924 NW Greenbrier Pkwy.
Beaverton,  OR  97006
Applicant Contact JAMES W SANDBERG
Correspondent
Protocol Systems, Inc.
14924 NW Greenbrier Pkwy.
Beaverton,  OR  97006
Correspondent Contact JAMES W SANDBERG
Regulation Number870.2300
Classification Product Code
DRT  
Date Received03/01/1991
Decision Date 05/08/1991
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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