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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 K153353
Device Name SANDMAN ELITE
Applicant
EMBLA SYSTEMS
1 HINES ROAD SUITE 202
KANATA,  CA K2K 3C7
Applicant Contact SHANE T. SAWALL
Correspondent
EMBLA SYSTEMS
1 HINES ROAD SUITE 202
KANATA,  CA K2K 3C7
Correspondent Contact SHANE T. SAWALL
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received11/20/2015
Decision Date 06/23/2016
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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