ALPHA OMEGA ENGINEERING CO. LTD.

Address:Hamerkava St. 6,Nof HaGalil Northern,IL

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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, Depth (GZL) (10)

Premarket Exempt

Clear

NeuroFortis Neuro Omega Drive HeadStage KIT - 27290016450136 Catalog Number : 750-020070-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroNav MER HeadStage KIT - 27290016450143 Catalog Number : 700-025023-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroSmart MER HeadStage Kit - 27290016450150 Catalog Number : 700-026009-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Neuro Omega MER HeadStage KIT - 27290016450167 Catalog Number : 750-020024-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroNav Drive Headstage Kit - 27290016450174 Catalog Number : 700-026000-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroOmega Drive Headstage Kit - 27290016450198 Catalog Number : 750-020021-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

Neuro Omega Autoclavable Drive Headstage KIT - 27290016450211 Catalog Number : 750-020025-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroSmart Autoclavable Drive Headstage Kit - 27290016450228 Catalog Number : 700-026008-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NexDrive Electrode Holder - 27290016450242 Catalog Number : 700-000316-02

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : No

Device Count : 1

NexFrame Mechanical Set Kit - 27290016450815 Catalog Number : 700-021507-03

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : No

Device Count : 1

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