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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 K873680
Device Name MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
Applicant
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Applicant Contact MICHAEL J SMITH
Correspondent
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Correspondent Contact MICHAEL J SMITH
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/14/1987
Decision Date 11/23/1987
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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