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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K012011
Device Name MODIFICATION TO A620 EEG
Applicant
Stoelting Co.
620 Wheat Ln.
Wood Dale,  IL  60191
Applicant Contact KENNETH L BIRD
Correspondent
Stoelting Co.
620 Wheat Ln.
Wood Dale,  IL  60191
Correspondent Contact KENNETH L BIRD
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/28/2001
Decision Date 10/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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