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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 K093223
Device Name COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
Applicant
Compumedics Limited
30-40 Flockhart St.
Abbotsford, Victoria,  AU 3067
Applicant Contact STUART KING
Correspondent
Compumedics Limited
30-40 Flockhart St.
Abbotsford, Victoria,  AU 3067
Correspondent Contact STUART KING
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
OLV   OLZ  
Date Received10/13/2009
Decision Date 01/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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