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 a medical device manufactured by Neauvia North America, Inc.. It received FDA 510(k) clearance on 2021-12-09 under approval 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. It is manufactured by Neauvia North America, Inc.. The 510(k) number is K212329.
When was Plasma IQ approved by the FDA?
Plasma IQ received FDA 510(k) clearance on 2021-12-09, under approval number K212329.
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.
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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.