FDA 510(k) Application Details - K963631

Device Classification Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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510(K) Number K963631
Device Name Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant OMEGA RESULTS
3322 SHORECREST, SUITE 235
DALLAS, TX 75235 US
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Contact KAY SPIEKERMAN EASON
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Regulation Number 882.1400

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Classification Product Code OLZ
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Date Received 09/11/1996
Decision Date 04/02/1997
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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