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FDA 510(k), K182181, Persyst 14 EEG Review and Analysis Software
FDA 510(k), K182181, Persyst 14 EEG Review and Analysis Software
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510(K) Number: K182181
Device Name: Persyst 14 EEG Review and Analysis Software
Manufacturer: Persyst Development Corporation
Device Classification Name: Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 08/13/2018
Decision Date: 11/29/2018
Regulation Medical Specialty: Neurology
Device Name: Persyst 14 EEG Review and Analysis Software
Manufacturer: Persyst Development Corporation
Device Classification Name: Automatic Event Detection Software For Full-Montage Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMB
Date Received: 08/13/2018
Decision Date: 11/29/2018
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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