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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 K042309
Device Name BIOSOMNIA-V3
Applicant
Oxford Biosignals Limited
611 Riggin Rd.
Troy,  IL  62294
Applicant Contact SIMON J GRIFFIN
Correspondent
Oxford Biosignals Limited
611 Riggin Rd.
Troy,  IL  62294
Correspondent Contact SIMON J GRIFFIN
Regulation Number882.1400
Classification Product Code
OMC  
Subsequent Product Code
OLV  
Date Received08/25/2004
Decision Date 09/08/2004
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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