FDA 510(K), K081151, COMPUMEDICS NEUVO

FDA 510(K), K081151, COMPUMEDICS NEUVO

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Device Classification Name    Full-Montage Standard Electroencephalograph
510(k) Number    K081151
Device Name    COMPUMEDICS NEUVO
Applicant    COMPUMEDICS USA, LTD.
Regulation Number    882.1400
Classification Product Code    GWQ  
Subsequent Product Codes    GWE      GWF      GWJ  
Date Received    04/23/2008
Decision Date    09/08/2008
Decision    Substantially Equivalent (SESE)
Regulation Medical Specialty    Neurology

Total pages: 364
Fully redacted pages: 85
Content pages: 279

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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