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FDA 510(k), K141316, COGNISION EEG/EP SYSTEM
FDA 510(k), K141316, COGNISION EEG/EP SYSTEM
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510(K) Number: K141316
Device Name: COGNISION EEG/EP SYSTEM
Manufacturer: NEURONETRIX SOLUTIONS
Device Classification Name: Non-Normalizing Quantitative Electroencephalograph Software
Regulation Number: 882.1400
Classification Product Code: OLT
Date Received: 05/20/2014
Decision Date: 02/13/2015
Regulation Medical Specialty: Neurology
Device Name: COGNISION EEG/EP SYSTEM
Manufacturer: NEURONETRIX SOLUTIONS
Device Classification Name: Non-Normalizing Quantitative Electroencephalograph Software
Regulation Number: 882.1400
Classification Product Code: OLT
Date Received: 05/20/2014
Decision Date: 02/13/2015
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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