hyperion X5, NewTom GO, X-RADiUS COMPACT
K-Number: K200688 · 2020-04-09
ApplicantCefla S.C.
Decision Date2020-04-09
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
hyperion X5, NewTom GO, X-RADiUS COMPACT is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2020-04-09 under approval number K200688. 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 hyperion X5, NewTom GO, X-RADiUS COMPACT?
hyperion X5, NewTom GO, X-RADiUS COMPACT is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by Cefla S.C.. The 510(k) number is K200688.
When was hyperion X5, NewTom GO, X-RADiUS COMPACT approved by the FDA?
hyperion X5, NewTom GO, X-RADiUS COMPACT received FDA 510(k) clearance on 2020-04-09, under approval number K200688.
What company makes hyperion X5, NewTom GO, X-RADiUS COMPACT?
hyperion X5, NewTom GO, X-RADiUS COMPACT is manufactured by Cefla S.C..
What is the FDA product code for hyperion X5, NewTom GO, X-RADiUS COMPACT?
The FDA product code for hyperion X5, NewTom GO, X-RADiUS COMPACT 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.