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FDA 510(k)

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

K-Number: K221144 · 2022-05-13

ApplicantRadisen Co., Ltd.
Decision Date2022-05-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG is a medical device manufactured by Radisen Co., Ltd.. It received FDA 510(k) clearance on 2022-05-13 under approval number K221144. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG?

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Radisen Co., Ltd.. The 510(k) number is K221144.

When was PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG approved by the FDA?

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG received FDA 510(k) clearance on 2022-05-13, under approval number K221144.

What company makes PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG?

PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG is manufactured by Radisen Co., Ltd..

What is the FDA product code for PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG?

The FDA product code for PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG is MQB.

Other Devices by Radisen Co., Ltd.

K213520AXIR-CX

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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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