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FDA 510(k) Application Details - K963631
Device Classification Name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OLZ
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More FDA Info for this Product Code
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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