FDA 510(k), K151929, PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE

FDA 510(k), K151929, PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE

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510(K) Number: K151929
Device Name: PERSYST 13 (P13) 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: 07/14/2015
Decision Date: 08/12/2015
Regulation Medical Specialty: Neurology

Total pages: 1,263

Fully redacted pages: 644

Content pages: 619

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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