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FDA 510(k)

3MP Color LCD Monitor, RadiForce RX350

K-Number: K153354 · 2016-01-12

Decision Date2016-01-12
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3MP Color LCD Monitor, RadiForce RX350 is a medical device manufactured by Eizo Corporation. It received FDA 510(k) clearance on 2016-01-12 under approval number K153354. 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 3MP Color LCD Monitor, RadiForce RX350?

3MP Color LCD Monitor, RadiForce RX350 is a medical device that received FDA 510(k) clearance on 2016-01-12. It is manufactured by Eizo Corporation. The 510(k) number is K153354.

When was 3MP Color LCD Monitor, RadiForce RX350 approved by the FDA?

3MP Color LCD Monitor, RadiForce RX350 received FDA 510(k) clearance on 2016-01-12, under approval number K153354.

What company makes 3MP Color LCD Monitor, RadiForce RX350?

3MP Color LCD Monitor, RadiForce RX350 is manufactured by Eizo Corporation.

What is the FDA product code for 3MP Color LCD Monitor, RadiForce RX350?

The FDA product code for 3MP Color LCD Monitor, RadiForce RX350 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.