FDA 510(k), K183453, VS3-IR

FDA 510(k), K183453, VS3-IR

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510(K) Number: K183453
Device Name: VS3-IR
Manufacturer: Medtronic
Device Classification Name: confocal optical imaging
Regulation Number: 876.1500
Classification Product Code: OWN
Date Received: 12/13/2018
Decision Date: 03/04/2019
Regulation Medical Specialty: Gastroenterology/Urology

Total pages: 1,049  
Fully redacted pages: 761  
Content pages: 288 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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