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

Electrode, Cutaneous (GXY) (7) Full-Montage Standard Electroencephalograph (GWQ) (2) Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB) (1)

Premarket Exempt

Yes No

Clear

Natus - 00382830016407 Catalog Number :

Device Description : Natus Quantum Breakout to Breakout Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016414 Catalog Number :

Device Description : Natus Quantum Stim Input Cable, 8ft

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016421 Catalog Number :

Device Description : Natus Quantum Stim Daisy Chain Cable, 1 to 2, 41 in

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016438 Catalog Number :

Device Description : Natus Quantum Oximeter Adapter Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016445 Catalog Number :

Device Description : Quantum Breakout DC Input Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016452 Catalog Number :

Device Description : Natus Base DC Input Y Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016469 Catalog Number :

Device Description : Natus Quantum REF Jumper Cable, 3ft

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016476 Catalog Number :

Device Description : Natus Quantum Patient Event Button 30ft

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830016483 Catalog Number :

Device Description : Natus Quantum Patient Event Button 5ft

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830016643 Catalog Number :

Device Description : Connex/Brain Monitor Breakout Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMB

Prescription Use : Yes

Device Count : 1

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