FDA 510(k), K192764, NeuroOne Cortical Electrode

FDA 510(k), K192764, NeuroOne Cortical Electrode

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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

Total pages: 815  
Fully redacted pages: 704  
Content pages: 111  

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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