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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 K852883
Device Name MEDILOG M3
Applicant
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Applicant Contact JOHN K LAURIE
Correspondent
Oxford Medilog, Inc.
11526 53rd. St. N.
Clearwater,  FL  33520
Correspondent Contact JOHN K LAURIE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/09/1985
Decision Date 07/26/1985
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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