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FDA 510(k), K192764, NeuroOne Cortical Electrode
FDA 510(k), K192764, NeuroOne Cortical Electrode
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$149.00 USD
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510(K) Number: K192764
Device Name: NeuroOne Cortical Electrode
Manufacturer: NeuroOne, Inc.
Device Classification Name: Electrode, Cortical
Regulation Number: 882.1310
Classification Product Code: GYC
Date Received: 09/30/2019
Decision Date: 11/26/2019
Regulation Medical Specialty: Neurology
Device Name: NeuroOne Cortical Electrode
Manufacturer: NeuroOne, Inc.
Device Classification Name: Electrode, Cortical
Regulation Number: 882.1310
Classification Product Code: GYC
Date Received: 09/30/2019
Decision Date: 11/26/2019
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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