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) Stimulator, Electrical, Evoked Response (GWF) (4) Stimulator, Photic, Evoked Response (GWE) (2)

Premarket Exempt

Yes No

Clear

Natus - 00382830011006 Catalog Number :

Device Description : Protektor 32 Pulse Oximeter Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830011013 Catalog Number :

Device Description : Protektor 32 Ear Inserts

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830011235 Catalog Number :

Device Description : PROT ACQ/STIM Q/R POD KIT

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830011259 Catalog Number :

Device Description : Protektor 32 Auditory Stim H/phone

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830011280 Catalog Number :

Device Description : EMU40EX Digital Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830011297 Catalog Number :

Device Description : EMU40EX Breakout Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830015639 Catalog Number :

Device Description : TrexHD Head Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830015790 Catalog Number :

Device Description : Natus Photic Stim Kit

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

Natus - 00382830015950 Catalog Number :

Device Description : Nonin LP Trex cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

Natus - 00382830015967 Catalog Number :

Device Description : P32 Pulse Oxi LP Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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