FDA.report

510(k) K233886

Device
Ambu® aScope? Duodeno 2, Ambu® aBox? 2
Applicant
Ambu A/S
510(k) number
K233886
Product code
FDT
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-16
Date received
2023-12-08
Regulation
876.1500
Classification name
Duodenoscope And Accessories, Flexible/Rigid
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Mette Andersen
Address
Baltorpbakken 13 Ballerup DK 2750 2750

FDA Registration Numbers

Source Documents

510(k) summary PDF

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