Megin Oy

Address:Keilasatama 5,Espoo Uusimaa,FI

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Full-Montage Standard Electroencephalograph (GWQ) (6) Magnetoencephalograph (OLY) (4)

Premarket Exempt

Clear

60-channel cap (S) - 06430056480299 Catalog Number :

Device Description : 60-channel EEG cap (S) used with VectorView

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

60-channel cap (M) - 06430056480305 Catalog Number :

Device Description : 60-channel EEG cap (M) used with VectorView

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

60-channel cap (L) - 06430056480312 Catalog Number :

Device Description : 60-channel EEG cap (L) used with VectorView

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

124-channel cap (M) - 06430056480329 Catalog Number :

Device Description : 124-channel EEG cap (M) used with VectorView

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

Auditory stimulator earphones (VectorView) - 06430056480336 Catalog Number :

Device Description : Auditory Stimulator earphones used with VectorView

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

HPI coil set (VectorView) - 06430056480343 Catalog Number : NM20555N

Device Description : VectorView HPI coil set Individual OR Package of 1 HPI coil set in a box

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : GWQ

Prescription Use : No

Device Count : 1

Pediatric comfort set - 06430056480367 Catalog Number :

Device Description : Pediatric comfort set

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : OLY

Prescription Use : No

Device Count : 1

TRIUX™ neo chair - 06430056480374 Catalog Number :

Device Description : Adjustable patient chair with accessories for comfortable seated measurement position

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : OLY

Prescription Use : No

Device Count : 1

TRIUX™ neo couch - 06430056480381 Catalog Number :

Device Description : Patient couch for the supine measurement position

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : OLY

Prescription Use : No

Device Count : 1

TRIUX™ neo - 06430056480398 Catalog Number :

Device Description : The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

Device Class : 2

Duns Number: 538025107

Premarket Exempt : No

Product Code : OLY

Prescription Use : No

Device Count : 1

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