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FDA 510(k)

EZFluence

K-Number: K171352 · 2017-12-01

ApplicantRadformation, Inc.
Decision Date2017-12-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EZFluence is a medical device manufactured by Radformation, Inc.. It received FDA 510(k) clearance on 2017-12-01 under approval number K171352. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZFluence?

EZFluence is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Radformation, Inc.. The 510(k) number is K171352.

When was EZFluence approved by the FDA?

EZFluence received FDA 510(k) clearance on 2017-12-01, under approval number K171352.

What company makes EZFluence?

EZFluence is manufactured by Radformation, Inc..

What is the FDA product code for EZFluence?

The FDA product code for EZFluence is IYE.

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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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