XLTEK

XLTEK

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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) (5) Electromyograph, Diagnostic (IKN) (3) Cable, Electrode (IKD) (2)

Premarket Exempt

No Yes

Clear

Natus - 00382830000000 Catalog Number :

Device Description : Xltek NeuroMax 2 Channel Headbox with cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830000116 Catalog Number :

Device Description : EMU40 DIGITAL BOX WHITE

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830000123 Catalog Number :

Device Description : EMU40 BREAKOUT/B WHITE

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830000130 Catalog Number :

Device Description : LEMO PATIENT CALL CORD 2'

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830000147 Catalog Number :

Device Description : PATIENT EVENT BUTTON 8FT

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830000154 Catalog Number :

Device Description : LEMO PATIENT EVENT BUTTON - 30'

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830000222 Catalog Number :

Device Description : Reusable Stackable Jumper Linker Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Natus - 00382830000277 Catalog Number :

Device Description : Reusable Shielded 3-in-1 Monopolar Extension Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Natus - 00382830000567 Catalog Number :

Device Description : Xltek NeuroMax CE 1004 Main Unit - White

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830001250 Catalog Number :

Device Description : Xltek NeuroMax 4 Channel Headbox with cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

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