FDA 510(k), K171328, cNeuro cMRI

FDA 510(k), K171328, cNeuro cMRI

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510(K) Number: K171328
Device Name: cNeuro cMRI
Manufacturer: Combinostics Oy
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 05/05/2017
Decision Date: 01/08/2018
Regulation Medical Specialty: Radiology

Total pages: 1,872  
Fully redacted pages: 1,250  
Content pages: 622 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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