FDA.reportPublic FDA data

Neuro-IOM

Primary DI
04650075330371
Brand
Neuro-IOM
Company
NEUROSOFT, OOO
Model
Neuro-IOM
Device description
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status.The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations:I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist.
Published
2021-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response
GWFStimulator, Electrical, Evoked Response
GWJStimulator, Auditory, Evoked Response
OLTNon-Normalizing Quantitative Electroencephalograph Software
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2
GWFStimulator, Electrical, Evoked ResponseNeurology2
GWJStimulator, Auditory, Evoked ResponseNeurology2
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190703000Neuro-IOM system with Neuro-IOM.NET softwareNeurosoft , Ltd.2021-05-22GWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04650075330371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04650075330371046500753303714650075330371

GMDN Terms#

Term, Definition table
TermDefinition
Neurophysiologic monitoring systemAn assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of accidental injury during instrumented spine surgery, or to diagnose acute dysfunction in corticospinal conduction (e.g., due to traction, shearing, laceration, compression, or vascular insufficiency). It typically displays electroencephalogram (EEG), electromyogram (EMG), and/or evoked responses. It typically includes an electric current pulse generator, electrodes and/or probes, and audible and/or visual indicators.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617 8403253Jjabre@teleemg.com

Regulatory Flags#

DUNS number
643212926
Device count
1
Serial number
true
Manufacturing date on label
true

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