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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 K910972
Device Name WALTER GRAPHTEK
Applicant
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79321
Applicant Contact SASCHKA BUSCH
Correspondent
Inomed Medizintechnik GmbH
Im Hausgruen 29
Emmendingen,  DE 79321
Correspondent Contact SASCHKA BUSCH
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received03/07/1991
Decision Date 10/02/1991
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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