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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K890711
Device Name DUAL GRAPH (TM) RECORDER-MONITOR
Applicant
Somatics, Inc.
910 Sherwood Dr., Unit 17
Lake Bluff,  IL  60044
Applicant Contact ABRAMS, M.D.
Correspondent
Somatics, Inc.
910 Sherwood Dr., Unit 17
Lake Bluff,  IL  60044
Correspondent Contact ABRAMS, M.D.
Regulation Number870.2810
Classification Product Code
DSF  
Date Received02/13/1989
Decision Date 06/02/1989
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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