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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K850418
Device Name BUSHEL OFF-HEAD PREAMPLIFIER
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 Number882.1400
Classification Product Code
GWQ  
Date Received02/04/1985
Decision Date 06/13/1985
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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