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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K920294
Device Name SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM
Applicant
Stuart Medical, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact LYNNE ARONSON
Correspondent
Stuart Medical, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact LYNNE ARONSON
Classification Product Code
LOS
Date Received01/22/1992
Decision Date 07/07/1992
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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