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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 K021485
Device Name BIOSOMNIA
Applicant
Oxford Biosignals Limited
1468 Harwell Ave.
Crofton,  MD  21114
Applicant Contact PAUL A HOBDAY
Correspondent
Oxford Biosignals Limited
1468 Harwell Ave.
Crofton,  MD  21114
Correspondent Contact PAUL A HOBDAY
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
OLV  
Date Received05/08/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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