Ambu® aScope Duodeno 2, Ambu® aBox 2
K-Number: K233886 · 2024-04-16
ApplicantAmbu A/S
Decision Date2024-04-16
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ambu® aScope Duodeno 2, Ambu® aBox 2 is a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2024-04-16 under approval number K233886. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambu® aScope Duodeno 2, Ambu® aBox 2?
Ambu® aScope Duodeno 2, Ambu® aBox 2 is a medical device that received FDA 510(k) clearance on 2024-04-16. It is manufactured by Ambu A/S. The 510(k) number is K233886.
When was Ambu® aScope Duodeno 2, Ambu® aBox 2 approved by the FDA?
Ambu® aScope Duodeno 2, Ambu® aBox 2 received FDA 510(k) clearance on 2024-04-16, under approval number K233886.
What company makes Ambu® aScope Duodeno 2, Ambu® aBox 2?
Ambu® aScope Duodeno 2, Ambu® aBox 2 is manufactured by Ambu A/S.
What is the FDA product code for Ambu® aScope Duodeno 2, Ambu® aBox 2?
The FDA product code for Ambu® aScope Duodeno 2, Ambu® aBox 2 is FDT.
Other Devices by Ambu A/S
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.