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FDA 510(k)

Afina

K-Number: K181501 · 2018-11-02

ApplicantNeurovision Imaging, LLC
Decision Date2018-11-02
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Afina is a medical device manufactured by Neurovision Imaging, LLC. It received FDA 510(k) clearance on 2018-11-02 under approval number K181501. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Afina?

Afina is a medical device that received FDA 510(k) clearance on 2018-11-02. It is manufactured by Neurovision Imaging, LLC. The 510(k) number is K181501.

When was Afina approved by the FDA?

Afina received FDA 510(k) clearance on 2018-11-02, under approval number K181501.

What company makes Afina?

Afina is manufactured by Neurovision Imaging, LLC.

What is the FDA product code for Afina?

The FDA product code for Afina is NFJ.

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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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