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) (7) Electrode, Cutaneous (GXY) (2) Electromyograph, Diagnostic (IKN) (1)

Premarket Exempt

Yes No

Clear

Natus - 00382830016094 Catalog Number :

Device Description : AUDITORY STIMULATION HEADPHONES FOR XLTEK NEUROMAX

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830016315 Catalog Number :

Device Description : Natus Quantum Base Unit

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016322 Catalog Number :

Device Description : Natus Quantum Breakout Main

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016339 Catalog Number :

Device Description : Natus Quantum Breakout B

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016346 Catalog Number :

Device Description : Natus Quantum Pin Box 1-64

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016353 Catalog Number :

Device Description : Natus Quantum Pin Box 65-128

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016360 Catalog Number :

Device Description : Natus Quantum Pin Box 129-192

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016377 Catalog Number :

Device Description : Natus Quantum Pin Box 193-256

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016384 Catalog Number :

Device Description : Natus Quantum Breakout to Base Cable, 33 ft (10m)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016391 Catalog Number :

Device Description : Natus Quantum Breakout to Base Cable, 16 ft (5m)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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