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FDA 510(k), K212382, Ambu® aScope™ Gastro, Ambu® aBox™2
FDA 510(k), K212382, Ambu® aScope™ Gastro, Ambu® aBox™2
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510(K) Number: K212382
Device Name: Ambu® aScope™ Gastro, Ambu® aBox™2
Manufacturer: Ambu A/S
Device Classification Name: Gastroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDS
Date Received: 08/02/2021
Decision Date: 02/03/2022
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Ambu® aScope™ Gastro, Ambu® aBox™2
Manufacturer: Ambu A/S
Device Classification Name: Gastroscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDS
Date Received: 08/02/2021
Decision Date: 02/03/2022
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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