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FDA 510(k)

Axiom PX

K-Number: K161177 · 2017-06-15

ApplicantAnthogyr Sas
Decision Date2017-06-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Axiom PX is a medical device manufactured by Anthogyr Sas. It received FDA 510(k) clearance on 2017-06-15 under approval number K161177. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axiom PX?

Axiom PX is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Anthogyr Sas. The 510(k) number is K161177.

When was Axiom PX approved by the FDA?

Axiom PX received FDA 510(k) clearance on 2017-06-15, under approval number K161177.

What company makes Axiom PX?

Axiom PX is manufactured by Anthogyr Sas.

What is the FDA product code for Axiom PX?

The FDA product code for Axiom PX is DZE.

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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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