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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 K902586
Device Name GRI LASERGRAPH(TM) ECG PAPER
Applicant
Gri Medical Products, Inc.
P.O. Box 601
Norwalk,  CT  06852
Applicant Contact STEPHEN B SNIDER
Correspondent
Gri Medical Products, Inc.
P.O. Box 601
Norwalk,  CT  06852
Correspondent Contact STEPHEN B SNIDER
Regulation Number870.2810
Classification Product Code
DSF  
Date Received06/12/1990
Decision Date 06/22/1990
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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