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FDA 510(k)

ION MAGNUM GENIUS

K-Number: K123158 · 2013-06-21

ApplicantIon Genius, Inc.
Decision Date2013-06-21
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ION MAGNUM GENIUS is the device name listed in this FDA 510(k) record. The listed applicant is Ion Genius, Inc.. It received FDA 510(k) clearance on 2013-06-21 under 510(k) number K123158. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION MAGNUM GENIUS?

ION MAGNUM GENIUS is a medical device that received FDA 510(k) clearance on 2013-06-21. The listed applicant is Ion Genius, Inc.. The 510(k) number is K123158.

When did ION MAGNUM GENIUS receive FDA 510(k) clearance?

ION MAGNUM GENIUS received FDA 510(k) clearance on 2013-06-21, under 510(k) number K123158.

Who is the listed applicant for ION MAGNUM GENIUS?

The FDA 510(k) record lists Ion Genius, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ION MAGNUM GENIUS?

The FDA product code for ION MAGNUM GENIUS is NGX.

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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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