Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Plasma IQ

K-Number: K223222 · 2023-01-17

ApplicantNeauvia North America, Inc.
Decision Date2023-01-17
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 2023-01-17 under approval number K223222. 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 2023-01-17. It is manufactured by Neauvia North America, Inc.. The 510(k) number is K223222.

When was Plasma IQ approved by the FDA?

Plasma IQ received FDA 510(k) clearance on 2023-01-17, under approval number K223222.

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.

K192813Plasma IQ K212329Plasma IQ

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑