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FDA 510(k)

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

K-Number: K190496 · 2019-04-24

ApplicantCefla S.C.
Decision Date2019-04-24
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2019-04-24 under approval number K190496. 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 X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is a medical device that received FDA 510(k) clearance on 2019-04-24. It is manufactured by Cefla S.C.. The 510(k) number is K190496.

When was hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS approved by the FDA?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS received FDA 510(k) clearance on 2019-04-24, under approval number K190496.

What company makes hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is manufactured by Cefla S.C..

What is the FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

The FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS 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.

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