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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 K871045
Device Name DMI AMBULATORY HOLTER MONITOR
Applicant
Diagnostic Medical Instruments
6724 Thompson Rd.
Syracuse,  NY  13211
Applicant Contact FREDERICK V CANNITO
Correspondent
Diagnostic Medical Instruments
6724 Thompson Rd.
Syracuse,  NY  13211
Correspondent Contact FREDERICK V CANNITO
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/17/1987
Decision Date 05/19/1987
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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