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

Electromyograph, Diagnostic (IKN) (4) Stimulator, Electrical, Evoked Response (GWF) (4) Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB) (2)

Premarket Exempt

No Yes

Clear

Natus - 00382830001267 Catalog Number :

Device Description : P32 ACQ POD 2 - 10' (CR)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830002264 Catalog Number :

Device Description : NEUROMAX OPTO-ISO

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830002325 Catalog Number :

Device Description : Xltek NeuroMax CE 1002 Main Unit - White

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830002356 Catalog Number :

Device Description : P32 ACQ POD 3 - 10' (CR)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830002370 Catalog Number :

Device Description : Xltek NeuroMax CE 1002 Main Unit - White Export

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830002387 Catalog Number :

Device Description : P32 ACQ POD 2 - 20' (CR)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830002394 Catalog Number :

Device Description : P32 ACQ POD 4 - 20' (CR)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830002424 Catalog Number :

Device Description : XCALIBUR LT MAIN UNIT

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : IKN

Prescription Use : Yes

Device Count : 1

Natus - 00382830002493 Catalog Number :

Device Description : ICU BREAKOUT BOX WHITE

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMB

Prescription Use : Yes

Device Count : 1

Natus - 00382830002516 Catalog Number :

Device Description : ICU DIGITAL BOX WHITE

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMB

Prescription Use : Yes

Device Count : 1

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