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FDA 510(k), K201098, Ambu Duodeno System
FDA 510(k), K201098, Ambu Duodeno System
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510(K) Number: K201098
Device Name: Ambu Duodeno System
Manufacturer: Oliver V Ruepprecht
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: 04/24/2020
Date Received: 07/17/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Ambu Duodeno System
Manufacturer: Oliver V Ruepprecht
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: FDT
Classification Product Code: 04/24/2020
Date Received: 07/17/2020
Decision Date: Substantially Equivalent (SESE)
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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