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FDA 510(k)

Mobius3D

K-Number: K153014 · 2016-04-29

ApplicantMobius Medical Systems, LP
Decision Date2016-04-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mobius3D is a medical device manufactured by Mobius Medical Systems, LP. It received FDA 510(k) clearance on 2016-04-29 under approval number K153014. 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 Mobius3D?

Mobius3D is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Mobius Medical Systems, LP. The 510(k) number is K153014.

When was Mobius3D approved by the FDA?

Mobius3D received FDA 510(k) clearance on 2016-04-29, under approval number K153014.

What company makes Mobius3D?

Mobius3D is manufactured by Mobius Medical Systems, LP.

What is the FDA product code for Mobius3D?

The FDA product code for Mobius3D is IYE.

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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.

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