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FDA 510(k), K141358, CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
FDA 510(k), K141358, CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
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510(K) Number: K141358
Device Name: CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
Manufacturer: MAUNA KEA TECHNOLOGIES
Device Classification Name: confocal optical imaging
Regulation Number: 876.1500
Classification Product Code: OWN
Date Received: 05/23/2014
Decision Date: 09/25/2014
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES
Manufacturer: MAUNA KEA TECHNOLOGIES
Device Classification Name: confocal optical imaging
Regulation Number: 876.1500
Classification Product Code: OWN
Date Received: 05/23/2014
Decision Date: 09/25/2014
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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