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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K913600
Device Name WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM
Applicant
Ralin Laboratories, Inc.
8199 SW Nimbus Ave.
Bldg. Eleven
Beaverton,  OR  97005
Applicant Contact DONALD M OWEN
Correspondent
Ralin Laboratories, Inc.
8199 SW Nimbus Ave.
Bldg. Eleven
Beaverton,  OR  97005
Correspondent Contact DONALD M OWEN
Regulation Number870.2800
Classification Product Code
DSH  
Date Received08/13/1991
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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