FDA 510(k), K143233, Mitsar-EEG
FDA 510(k), K143233, Mitsar-EEG
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510(K) Number: K143233
Device Name: Mitsar-EEG
Manufacturer: Semchenkov Ales
Device Classification Name: Full-Montage Standard Electroencephalograph
Regulation Number: GWQ
Classification Product Code: 11/10/2014
Date Received: 08/13/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Mitsar-EEG
Manufacturer: Semchenkov Ales
Device Classification Name: Full-Montage Standard Electroencephalograph
Regulation Number: GWQ
Classification Product Code: 11/10/2014
Date Received: 08/13/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology