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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K911615
Device Name HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300
Applicant
Diagnostic Monitoring Software
17300 Seventeenth St.
J-344
Tustin,  CA  92680
Applicant Contact JERRY FAILS
Correspondent
Diagnostic Monitoring Software
17300 Seventeenth St.
J-344
Tustin,  CA  92680
Correspondent Contact JERRY FAILS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/11/1991
Decision Date 01/08/1992
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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