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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 K963631
Device Name SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
Applicant
OMEGA RESULTS
3322 SHORECREST, SUITE 235
DALLAS,  TX  75235
Applicant Contact KAY SPIEKERMAN EASON
Correspondent
OMEGA RESULTS
3322 SHORECREST, SUITE 235
DALLAS,  TX  75235
Correspondent Contact KAY SPIEKERMAN EASON
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received09/11/1996
Decision Date 04/02/1997
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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