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FDA 510(k)

Plasma IQ

K-Number: K192813 · 2020-03-06

ApplicantNeauvia North America, Inc.
Decision Date2020-03-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plasma IQ is a medical device manufactured by Neauvia North America, Inc.. It received FDA 510(k) clearance on 2020-03-06 under approval number K192813. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plasma IQ?

Plasma IQ is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by Neauvia North America, Inc.. The 510(k) number is K192813.

When was Plasma IQ approved by the FDA?

Plasma IQ received FDA 510(k) clearance on 2020-03-06, under approval number K192813.

What company makes Plasma IQ?

Plasma IQ is manufactured by Neauvia North America, Inc..

What is the FDA product code for Plasma IQ?

The FDA product code for Plasma IQ is GEI.

Other Devices by Neauvia North America, Inc.

K212329Plasma IQ K223222Plasma IQ

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Official Source

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