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

Stimulator, Electrical, Evoked Response (GWF) (4) Amplitude-Integrated Electroencephalograph (OMA) (3) Automatic Event Detection Software For Full-Montage Electroencephalograph (OMB) (2) Full-Montage Standard Electroencephalograph (GWQ) (1) Reduced- Montage Standard Electroencephalograph (OMC) (1)

Premarket Exempt

No Yes

Clear

Natus - 00382830008679 Catalog Number :

Device Description : OBM Positioning Strips

Device Class : 2

Duns Number: 245258280

Premarket Exempt : Yes

Product Code : OMA

Prescription Use : Yes

Device Count : 1

Natus - 00382830009072 Catalog Number :

Device Description : SLEEP BREAKOUT Brain Monitor

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMB

Prescription Use : Yes

Device Count : 1

Natus - 00382830009171 Catalog Number :

Device Description : EXTERNAL EMU40 BATTERY PACK

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

Natus - 00382830010818 Catalog Number :

Device Description : OBM Main Unit

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMA

Prescription Use : Yes

Device Count : 1

Natus - 00382830010825 Catalog Number :

Device Description : OBM Data Acquisition Box (DAB)

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMA

Prescription Use : Yes

Device Count : 1

Natus - 00382830010924 Catalog Number :

Device Description : OBM Main Unit - V3.1.5

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : OMC, OMB

Prescription Use : Yes

Device Count : 1

Natus - 00382830010955 Catalog Number :

Device Description : Protektor 32 - Isolation Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830010962 Catalog Number :

Device Description : Protektor 32 Stimulation Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830010979 Catalog Number :

Device Description : Protektor 32 Acquisition Box

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

Natus - 00382830010986 Catalog Number :

Device Description : Protektor 32 Cautery Detector

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GWF

Prescription Use : Yes

Device Count : 1

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