FDA.reportPublic FDA data

60-channel cap (S)

Primary DI
06430056480299
Brand
60-channel cap (S)
Company
Megin Oy
Model
NM20885N
Device description
60-channel EEG cap (S) 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
Rx
true
OTC
false
Sterile
false
Single use
false

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
06430056480299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430056480299064300564802996430056480299

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0643005648014564-channel EEG cap (S)NM24301NNM23890N2016-09-23
0643005648011432-channel EEG cap (S)NM24430NNM23905N2016-09-23
06430056480343HPI coil set (VectorView)NM20555XNM20555N2016-09-23
06430056480039MaxFilter™ 2.2SW24051N2025-05-23
06430056480008Elekta Neuromag® TRIUXNM23900N2016-09-23
06430056480015Elekta Neuromag® TRIUXNM25000N2016-09-23
06430056480022Data analysis software 3.4SW23380N2016-09-23
06430056480046MaxFilter™ 2.2SW25613N2016-09-23
06430056480053Patient chairNM23124N2016-09-23
06430056480060Patient couchNM23125N2016-09-23
06430056480077Child insert for chairBC20899N2016-09-23
06430056480084Auditory stimulator (earphones)NM24035N2016-09-23
06430056480091Bilateral finger response systemNM20999N2016-09-23
06430056480107Head position coil setNM23880N2016-09-23
0643005648012132-channel EEG cap (M)NM24431NNM23906N2016-09-23
0643005648013832-channel EEG cap (L)NM24432NNM23907N2016-09-23
06430056480282SEF electrode assemblyNM21794K2016-09-23
0643005648030560-channel cap (M)NM20884N2016-09-23
0643005648031260-channel cap (L)NM20886N2016-09-23
06430056480329124-channel cap (M)NM21302N2016-09-23

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