RT Elements (4.0)
K-Number: K223279 · 2023-03-14
ApplicantBrainlab AG
Decision Date2023-03-14
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RT Elements (4.0) is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2023-03-14 under approval number K223279. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RT Elements (4.0)?
RT Elements (4.0) is a medical device that received FDA 510(k) clearance on 2023-03-14. It is manufactured by Brainlab AG. The 510(k) number is K223279.
When was RT Elements (4.0) approved by the FDA?
RT Elements (4.0) received FDA 510(k) clearance on 2023-03-14, under approval number K223279.
What company makes RT Elements (4.0)?
RT Elements (4.0) is manufactured by Brainlab AG.
What is the FDA product code for RT Elements (4.0)?
The FDA product code for RT Elements (4.0) is MUJ.
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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.