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FDA 510(k)

NEUROMARK System

K-Number: K222032 · 2022-10-26

ApplicantNeurent Medical
Decision Date2022-10-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEUROMARK System is a medical device manufactured by Neurent Medical. It received FDA 510(k) clearance on 2022-10-26 under approval number K222032. 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 NEUROMARK System?

NEUROMARK System is a medical device that received FDA 510(k) clearance on 2022-10-26. It is manufactured by Neurent Medical. The 510(k) number is K222032.

When was NEUROMARK System approved by the FDA?

NEUROMARK System received FDA 510(k) clearance on 2022-10-26, under approval number K222032.

What company makes NEUROMARK System?

NEUROMARK System is manufactured by Neurent Medical.

What is the FDA product code for NEUROMARK System?

The FDA product code for NEUROMARK System is GEI.

Related Clinical Trials

NCT05591989 Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON) COMPLETED

Other Devices by Neurent Medical

K212666Neuromark System

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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.

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