FDA 510(k), K173244, superDimension Navigation System V7.2

FDA 510(k), K173244, superDimension Navigation System V7.2

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510(K) Number: K173244
Device Name: superDimension Navigation System V7.2
Manufacturer: Covidien LLC
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 10/06/2017
Decision Date: 02/08/2018
Regulation Medical Specialty: Radiology

563 pages (1,812 of 2,375 original pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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