Monaco RTP System
K-Number: K223233 · 2023-02-23
ApplicantElekta Solutions AB
Decision Date2023-02-23
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Monaco RTP System is a medical device manufactured by Elekta Solutions AB. It received FDA 510(k) clearance on 2023-02-23 under approval number K223233. 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 Monaco RTP System?
Monaco RTP System is a medical device that received FDA 510(k) clearance on 2023-02-23. It is manufactured by Elekta Solutions AB. The 510(k) number is K223233.
When was Monaco RTP System approved by the FDA?
Monaco RTP System received FDA 510(k) clearance on 2023-02-23, under approval number K223233.
What company makes Monaco RTP System?
Monaco RTP System is manufactured by Elekta Solutions AB.
What is the FDA product code for Monaco RTP System?
The FDA product code for Monaco RTP System is MUJ.
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K213787Monaco RTP System
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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.