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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 K890114
Device Name IMEX RHYTHM TEK
Applicant
Racom, Inc.
Unit 1 Theale Tech. Centre
Station Rd. Theale, Reading
Rg7 4lp, Berkshire,  GB
Applicant Contact STEVE LANE
Correspondent
Racom, Inc.
Unit 1 Theale Tech. Centre
Station Rd. Theale, Reading
Rg7 4lp, Berkshire,  GB
Correspondent Contact STEVE LANE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received01/11/1989
Decision Date 07/27/1989
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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