FDA 510(k), K192245, Pentax Medical Video Duodenoscope ED34-i10T2
FDA 510(k), K192245, Pentax Medical Video Duodenoscope ED34-i10T2
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510(K) Number: K192245
Device Name: Pentax Medical Video Duodenoscope ED34-i10T2
Manufacturer: William Goeller
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: 08/19/2019
Date Received: 11/15/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Pentax Medical Video Duodenoscope ED34-i10T2
Manufacturer: William Goeller
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: 08/19/2019
Date Received: 11/15/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
- 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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