FDA 510(k), K212382, Ambu® aScope™ Gastro, Ambu® aBox™2

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