FDA.reportPublic FDA data

124-channel cap (M)

Primary DI
06430056480329
Brand
124-channel cap (M)
Company
Megin Oy
Model
NM21302N
Device description
124-channel EEG cap (M) used with VectorView
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041264000ELEKTA OYElekta Neuromag OY2004-08-10OLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430056480329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430056480329064300564803296430056480329

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
538025107
Device count
1
Serial number
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
06430056480343HPI coil set (VectorView)NM20555XNM20555N2016-09-23
0643005648029960-channel cap (S)NM20885N2016-09-23
0643005648030560-channel cap (M)NM20884N2016-09-23
0643005648031260-channel cap (L)NM20886N2016-09-23
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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