ZETO INC

Address:4917 Waters Edge Dr,Raleigh,NC,27606,US

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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) (2) Full-Montage Standard Electroencephalograph (GWQ) (1)

Premarket Exempt

Clear

Soft Flex-S - B675SOFTFLEXS1 Catalog Number : ZP-200-51011

Device Description : Soft Flex Electrodes - Short

Device Class :

Duns Number: 079582566

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 25

Soft Flex-T - B675SOFTFLEXT1 Catalog Number : ZP-200-53011

Device Description : Soft Flex Electrodes - Tall

Device Class :

Duns Number: 079582566

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 25

WR19 - B675WR190 Catalog Number :

Device Description : EEG Headset

Device Class : 2

Duns Number: 079582566

Premarket Exempt : No

Product Code : GWQ

Prescription Use : Yes

Device Count : 1

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