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FDA 510(k)

RadiForce RX1270, RadiForce RX1270-AR

K-Number: K200485 · 2020-03-23

Decision Date2020-03-23
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadiForce RX1270, RadiForce RX1270-AR is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2020-03-23 under approval number K200485. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RadiForce RX1270, RadiForce RX1270-AR?

RadiForce RX1270, RadiForce RX1270-AR is a medical device that received FDA 510(k) clearance on 2020-03-23. It is manufactured by Eizo Corporation. The 510(k) number is K200485.

When was RadiForce RX1270, RadiForce RX1270-AR approved by the FDA?

RadiForce RX1270, RadiForce RX1270-AR received FDA 510(k) clearance on 2020-03-23, under approval number K200485.

What company makes RadiForce RX1270, RadiForce RX1270-AR?

RadiForce RX1270, RadiForce RX1270-AR is manufactured by Eizo Corporation.

What is the FDA product code for RadiForce RX1270, RadiForce RX1270-AR?

The FDA product code for RadiForce RX1270, RadiForce RX1270-AR is PGY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.