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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Spectrum, Electroencephalogram Signal
510(k) Number K912938
FOIA Releasable 510(k) K912938
Device Name RHYTHM
Applicant
Stellate Systems
345 Victoria Ave., Suite 300
Westmount, Quebec,  CA H3Z 2N2
Applicant Contact GOTMAN
Correspondent
Stellate Systems
345 Victoria Ave., Suite 300
Westmount, Quebec,  CA H3Z 2N2
Correspondent Contact GOTMAN
Regulation Number882.1420
Classification Product Code
GWS  
Date Received07/05/1991
Decision Date 07/30/1991
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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