FDA.reportPublic FDA data

HPI coil set (VectorView)

Primary DI
06430056480350
Brand
HPI coil set (VectorView)
Company
Elekta 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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

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
06430056480350PackageGS12In 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
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
0643005648019032-channel EEG cap (S)NM24430NNM23905N2016-09-23

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