Ambu aScope 4 RhinoLaryngo Intervention
K-Number: K190972 · 2019-07-12
ApplicantAmbu A/S
Decision Date2019-07-12
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Ambu aScope 4 RhinoLaryngo Intervention is a medical device manufactured by Ambu A/S. It received FDA 510(k) clearance on 2019-07-12 under approval number K190972. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambu aScope 4 RhinoLaryngo Intervention?
Ambu aScope 4 RhinoLaryngo Intervention is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Ambu A/S. The 510(k) number is K190972.
When was Ambu aScope 4 RhinoLaryngo Intervention approved by the FDA?
Ambu aScope 4 RhinoLaryngo Intervention received FDA 510(k) clearance on 2019-07-12, under approval number K190972.
What company makes Ambu aScope 4 RhinoLaryngo Intervention?
Ambu aScope 4 RhinoLaryngo Intervention is manufactured by Ambu A/S.
What is the FDA product code for Ambu aScope 4 RhinoLaryngo Intervention?
The FDA product code for Ambu aScope 4 RhinoLaryngo Intervention is EOB.
Other Devices by Ambu A/S
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K160766Ambu USR, Ambu M
K181286Ambu aScope RLS Slim
K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
K191080Ambu aScope 4 RhinoLaryngo Slim
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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.