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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 K142988
Device Name Sleepware G3
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LANE
MURRYSVILLE,  PA  15668
Applicant Contact DANIELA AIZPITARTE
Correspondent
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE,  PA  15146
Correspondent Contact DANIELA AIZPITARTE
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Codes
MNR   OLV  
Date Received10/16/2014
Decision Date 03/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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