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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name full-montage standard electroencephalograph
510(k) Number K083577
Device Name HARMONIE SYSTEM
Original Applicant
STELLATE SYSTEMS
376 victoria avenue, suite 200
montreal, quebec,  CA h3z 1c3
Original Contact goldy singh
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received12/03/2008
Decision Date 08/29/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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