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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 K915856
Device Name SENSORMEDICS 4000 SERIES SLEEP SYSTEM
Applicant
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Applicant Contact RAUL L KITTINGER
Correspondent
Sensor Medics Corp.
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Correspondent Contact RAUL L KITTINGER
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received12/27/1991
Decision Date 10/26/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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