FDA 510(k)

NEUROMARK System (NMK00301)

K-Number: K250048 · 2025-05-29

Decision Date2025-05-29

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NEUROMARK System (NMK00301) is a medical device manufactured by Neurent Medical , Ltd.. It received FDA 510(k) clearance on 2025-05-29 under approval number K250048. 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 (NMK00301)?

NEUROMARK System (NMK00301) is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Neurent Medical , Ltd.. The 510(k) number is K250048.

When was NEUROMARK System (NMK00301) approved by the FDA?

NEUROMARK System (NMK00301) received FDA 510(k) clearance on 2025-05-29, under approval number K250048.

What company makes NEUROMARK System (NMK00301)?

NEUROMARK System (NMK00301) is manufactured by Neurent Medical , Ltd..

What is the FDA product code for NEUROMARK System (NMK00301)?

The FDA product code for NEUROMARK System (NMK00301) is GEI.

Related Clinical Trials

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

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.