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FDA 510(k), K193416, Cellvizio I.V.E. with Confocal Miniprobes
FDA 510(k), K193416, Cellvizio I.V.E. with Confocal Miniprobes
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$149.00 USD
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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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