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)

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software

K-Number: K170677 · 2017-04-05

ApplicantNeurovision Medical Product, Inc.
Decision Date2017-04-05
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software is a medical device manufactured by Neurovision Medical Product, Inc.. It received FDA 510(k) clearance on 2017-04-05 under approval number K170677. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurovision Nerve Locator Monitor (Nerveana), EMGView Software?

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software is a medical device that received FDA 510(k) clearance on 2017-04-05. It is manufactured by Neurovision Medical Product, Inc.. The 510(k) number is K170677.

When was Neurovision Nerve Locator Monitor (Nerveana), EMGView Software approved by the FDA?

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software received FDA 510(k) clearance on 2017-04-05, under approval number K170677.

What company makes Neurovision Nerve Locator Monitor (Nerveana), EMGView Software?

Neurovision Nerve Locator Monitor (Nerveana), EMGView Software is manufactured by Neurovision Medical Product, Inc..

What is the FDA product code for Neurovision Nerve Locator Monitor (Nerveana), EMGView Software?

The FDA product code for Neurovision Nerve Locator Monitor (Nerveana), EMGView Software is GWF.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT06482827 Treatment for Diabetic Neuropathy Using Repetitive Transcranial Magnetic Stimulation COMPLETED NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING

Related Devices (Code: GWF)

K160280MagPro R20Tonica Elektronik A/S K162873MEP MonitorTonica Elektronik A/S K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc. K182542The EPAD 2 SystemSafeop Surgical, Inc. K200759NIM Vital, Nerve Integrity MonitorMedtronic Xomed, Inc. K192823MEGA-TMSSoterix Medical, Inc.

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.

↑