FDA.reportPublic FDA data

HPI coil set (VectorView)

Primary DI
06430056480343
Brand
HPI coil set (VectorView)
Company
Megin Oy
Model
NM20555X
Catalog number
NM20555N
Device description
VectorView HPI coil set Individual OR Package of 1 HPI coil set in a box
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430056480350PackageGS12Not in Commercial Distribution
06430056480343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430056480350064300564803506430056480350
06430056480343064300564803436430056480343

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Regulatory Flags#

DUNS number
538025107
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430056480428Finger response padNM20928X2025-04-11
06430056480008Elekta Neuromag® TRIUXNM23900N2016-09-23
06430056480381TRIUX™ neo couchNM25906N 2018-04-30
06430056480039MaxFilter™ 2.2SW24051N2025-05-23
06430056480404MEGreview™SW26241N2025-05-23
06430056480411TRIUX™ neoNM27000N2025-05-23
0643005648029960-channel cap (S)NM20885N2016-09-23
0643005648030560-channel cap (M)NM20884N2016-09-23
0643005648031260-channel cap (L)NM20886N2016-09-23
06430056480329124-channel cap (M)NM21302N2016-09-23
06430056480336Auditory stimulator earphones (VectorView)EL21103J2016-09-23
0643005648011432-channel EEG cap (S)NM24430NNM23905N2016-09-23
0643005648012132-channel EEG cap (M)NM24431NNM23906N2016-09-23
0643005648013832-channel EEG cap (L)NM24432NNM23907N2016-09-23
06430056480015Elekta Neuromag® TRIUXNM25000N2016-09-23
06430056480022Data analysis software 3.4SW23380N2016-09-23
06430056480046MaxFilter™ 2.2SW25613N2016-09-23
06430056480053Patient chairNM23124N2016-09-23
06430056480060Patient couch NM23125N2016-09-23
06430056480077Child insert for chairBC20899N2016-09-23

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