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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 K894285
Device Name DMI PC HOLTER SCANNER
Applicant
Diagnostic Medical Instruments
6724 Thompson Rd.
Syracuse,  NY  13211
Applicant Contact FREDERICK CANNITO
Correspondent
Diagnostic Medical Instruments
6724 Thompson Rd.
Syracuse,  NY  13211
Correspondent Contact FREDERICK CANNITO
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/23/1989
Decision Date 09/26/1989
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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