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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reduced- Montage Standard Electroencephalograph
510(k) Number K781130
Device Name ACCESSORY TO ECG ANALYSIS SYS.
Applicant
OXFORD MEDILOG, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OXFORD MEDILOG, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1400
Classification Product Code
OMC  
Date Received07/05/1978
Decision Date 08/23/1978
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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