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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K881905
Device Name MODEL MICRO SI AMBULATORY ECG MONITOR
Applicant
Advanced Medical Products, Inc.
4709 Crossroads Park Dr.
Liverpool,  NY  13088
Applicant Contact JAMES H BROWN
Correspondent
Advanced Medical Products, Inc.
4709 Crossroads Park Dr.
Liverpool,  NY  13088
Correspondent Contact JAMES H BROWN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received05/06/1988
Decision Date 08/02/1988
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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