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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 K872508
Device Name MODEL MICRO FD+ AMBULATORY ECG MONITOR
Applicant
Advanced Medical Products, Inc.
Five Adler Dr.
E. Syracuse,  NY  13057
Applicant Contact JAMES H BROWN
Correspondent
Advanced Medical Products, Inc.
Five Adler Dr.
E. Syracuse,  NY  13057
Correspondent Contact JAMES H BROWN
Regulation Number870.2800
Classification Product Code
DSH  
Date Received06/24/1987
Decision Date 09/25/1987
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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