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FDA 510(k)

AXIR-CX

K-Number: K213520 · 2022-08-19

ApplicantRadisen Co., Ltd.
Decision Date2022-08-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXIR-CX is a medical device manufactured by Radisen Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under approval number K213520. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIR-CX?

AXIR-CX is a medical device that received FDA 510(k) clearance on 2022-08-19. It is manufactured by Radisen Co., Ltd.. The 510(k) number is K213520.

When was AXIR-CX approved by the FDA?

AXIR-CX received FDA 510(k) clearance on 2022-08-19, under approval number K213520.

What company makes AXIR-CX?

AXIR-CX is manufactured by Radisen Co., Ltd..

What is the FDA product code for AXIR-CX?

The FDA product code for AXIR-CX is LLZ.

Other Devices by Radisen Co., Ltd.

K221144PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG

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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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