FDA 510(k), K193416, Cellvizio I.V.E. with Confocal Miniprobes

510(K) Number: K193416
Device Name: Cellvizio I.V.E. with Confocal Miniprobes
Manufacturer: Mauna Kea Technologies
Device Classification Name: Confocal Optical Imaging
Regulation Number: 876.1500
Classification Product Code: OWN
Date Received: 12/09/2019
Decision Date: 02/28/2020
Regulation Medical Specialty: Gastroenterology/Urology

810 pages (1,005 of 1,815 original pages are fully redacted)