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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph
510(k) Number K961636
Device Name MEDILOG VISION
Applicant
Oxford Instruments, Plc.
11526 53rd.St. N.
Clearwater,  FL  34620
Applicant Contact CHARLES HOLZ
Correspondent
Oxford Instruments, Plc.
11526 53rd.St. N.
Clearwater,  FL  34620
Correspondent Contact CHARLES HOLZ
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received04/29/1996
Decision Date 01/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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