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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 K002622
Device Name BIOSLEEP
Applicant
OXFORD BIOSIGNALS LIMITED
OXFORD SCIENCE PARK
OXFORD, OX4 4 GA,  GB OX4 4
Applicant Contact PAULINE A HOBDAY
Correspondent
OXFORD BIOSIGNALS LIMITED
OXFORD SCIENCE PARK
OXFORD, OX4 4 GA,  GB OX4 4
Correspondent Contact PAULINE A HOBDAY
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received08/23/2000
Decision Date 10/23/2000
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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