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) (4) Electromyograph, Diagnostic (IKN) (3) Amplitude-Integrated Electroencephalograph (OMA) (1) Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB) (1) Device, Monitoring, Intracranial Pressure (GWM) (1)

Premarket Exempt

No Yes

Clear

Natus - 00382830002943 Catalog Number :

Device Description : Xltek NeuroMax CE 1004 Main Unit - White Export

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Natus - 00382830002950 Catalog Number :

Device Description : XCALIBUR ACQUISITION BREAKOUT

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830003001 Catalog Number :

Device Description : EEG32U Head Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830003049 Catalog Number :

Device Description : EMU128 Mini Breakout A (Blue)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830003063 Catalog Number :

Device Description : XCALIBUR / PROTEKTOR VISUAL EP GOGGLES 30'

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830003155 Catalog Number :

Device Description : AUDITORY STIMULATION HEADPHONES FOR XLTEK XCALIBUR

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830007047 Catalog Number :

Device Description : EMU40 Breakout w/ LMX9838 Bluetooth

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830007313 Catalog Number :

Device Description : EMU40 Digital Box w/ LMX9838 Bluetooth

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830007450 Catalog Number :

Device Description : Neonatal Sensors

Device Class : 2

Duns Number: 245258280

Premarket Exempt : Yes

Product Code : OMA

Prescription Use : Yes

Device Count : 60

Natus - 00382830008020 Catalog Number :

Device Description : OBM ROLL STAND KIT

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMB

Prescription Use : Yes

Device Count : 1

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