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FDA 510(k)

Plasma IQ

K-Number: K212329 · 2021-12-09

ApplicantNeauvia North America, Inc.
Decision Date2021-12-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plasma IQ is the device name listed in this FDA 510(k) record. The listed applicant is Neauvia North America, Inc.. It received FDA 510(k) clearance on 2021-12-09 under 510(k) number K212329. 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 2021-12-09. The listed applicant is Neauvia North America, Inc.. The 510(k) number is K212329.

When did Plasma IQ receive FDA 510(k) clearance?

Plasma IQ received FDA 510(k) clearance on 2021-12-09, under 510(k) number K212329.

Who is the listed applicant for Plasma IQ?

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

What is the FDA product code for Plasma IQ?

The FDA product code for Plasma IQ is GEI.

Other records listing Neauvia North America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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