EAGLE EDGE AXR90 and AXR120
K-Number: K210820 · 2021-08-10
Decision Date2021-08-10
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EAGLE EDGE AXR90 and AXR120 is a medical device manufactured by Alliage S/A Industrias Medico Odontológica. It received FDA 510(k) clearance on 2021-08-10 under approval number K210820. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EAGLE EDGE AXR90 and AXR120?
EAGLE EDGE AXR90 and AXR120 is a medical device that received FDA 510(k) clearance on 2021-08-10. It is manufactured by Alliage S/A Industrias Medico Odontológica. The 510(k) number is K210820.
When was EAGLE EDGE AXR90 and AXR120 approved by the FDA?
EAGLE EDGE AXR90 and AXR120 received FDA 510(k) clearance on 2021-08-10, under approval number K210820.
What company makes EAGLE EDGE AXR90 and AXR120?
EAGLE EDGE AXR90 and AXR120 is manufactured by Alliage S/A Industrias Medico Odontológica.
What is the FDA product code for EAGLE EDGE AXR90 and AXR120?
The FDA product code for EAGLE EDGE AXR90 and AXR120 is OAS.
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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.