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)

Neuro Omega System, NeuroSmart System

K-Number: K220553 · 2022-09-16

ApplicantAlpha Omega Engineering , Ltd.
Decision Date2022-09-16
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neuro Omega System, NeuroSmart System is a medical device manufactured by Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2022-09-16 under approval number K220553. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuro Omega System, NeuroSmart System?

Neuro Omega System, NeuroSmart System is a medical device that received FDA 510(k) clearance on 2022-09-16. It is manufactured by Alpha Omega Engineering , Ltd.. The 510(k) number is K220553.

When was Neuro Omega System, NeuroSmart System approved by the FDA?

Neuro Omega System, NeuroSmart System received FDA 510(k) clearance on 2022-09-16, under approval number K220553.

What company makes Neuro Omega System, NeuroSmart System?

Neuro Omega System, NeuroSmart System is manufactured by Alpha Omega Engineering , Ltd..

What is the FDA product code for Neuro Omega System, NeuroSmart System?

The FDA product code for Neuro Omega System, NeuroSmart System is GZL.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07026643 aVNT in POTS - Pilot NOT_YET_RECRUITING NCT06477016 OsciPulse D-dimer Pilot Trial RECRUITING

Other Devices by Alpha Omega Engineering , Ltd.

K171581Neuro Omega System K172042NeuroNav System, NeuroSmart System K191739Sterile LeadConfirm K250601Neuro Omega System; NeuroSmart System

Related Devices (Code: GZL)

K151790PMT Platinum Depthalon Depth ElectrodePmt Corporation K152547DNAP ElectrodeAd-Tech Medical Instrument Corporation K171581Neuro Omega SystemAlpha Omega Engineering , Ltd. K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical K162459AccuPoint ElectrodeMicroprobes For Life Science, Inc. Dba Neuron K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation

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.

↑