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FDA 510(k)

Navik 3D

K-Number: K152160 · 2016-02-23

ApplicantApn Health, LLC
Decision Date2016-02-23
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Navik 3D is a medical device manufactured by Apn Health, LLC. It received FDA 510(k) clearance on 2016-02-23 under approval number K152160. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navik 3D?

Navik 3D is a medical device that received FDA 510(k) clearance on 2016-02-23. It is manufactured by Apn Health, LLC. The 510(k) number is K152160.

When was Navik 3D approved by the FDA?

Navik 3D received FDA 510(k) clearance on 2016-02-23, under approval number K152160.

What company makes Navik 3D?

Navik 3D is manufactured by Apn Health, LLC.

What is the FDA product code for Navik 3D?

The FDA product code for Navik 3D is DQK.

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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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