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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 K002544
Device Name MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM
Applicant
OXFORD INSTRUMENTS
MANOR WAY
OLD WOKING, SURREY,  GB GU22 9JU
Applicant Contact BARRY BRIGHT
Correspondent
OXFORD INSTRUMENTS
MANOR WAY
OLD WOKING, SURREY,  GB GU22 9JU
Correspondent Contact BARRY BRIGHT
Regulation Number870.1425
Classification Product Code
DQK  
Date Received08/17/2000
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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