FDA 510(k) Application Details - K002622

Device Classification Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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510(K) Number K002622
Device Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant OXFORD BIOSIGNALS LIMITED
OXFORD SCIENCE PARK
OXFORD, OX4 4 GA OX4 4 GB
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Contact PAULINE A HOBDAY
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Regulation Number 882.1400

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Classification Product Code OLZ
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Date Received 08/23/2000
Decision Date 10/23/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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