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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 K891383
Device Name MEDILOG 9200 EEG REPLAY/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 Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received03/09/1989
Decision Date 06/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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