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) Electromyograph, Diagnostic (IKN) (1) Full-Montage Standard Electroencephalograph (GWQ) (1) Stimulator, Electrical, Evoked Response (GWF) (1)

Premarket Exempt

Clear

NeuroOmega System - 07290014954007 Catalog Number : NOM-000000-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : IKN, GWQ, GWF, GZL

Prescription Use : Yes

Device Count : 1

NeuroOmega Autoclavable - 07290014954014 Catalog Number : 750-000027-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroOmega Autoclavable - 07290014954021 Catalog Number : 750-000025-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroProbe - 07290014954038 Catalog Number : 366-050925-10

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : No

Device Count : 1

NeuroNav - 07290014954052 Catalog Number : 700-006002-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroNav Drive - 07290014954069 Catalog Number : 700-006000-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroProbe - 07290014954076 Catalog Number : STR-222291-00

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : No

Device Count : 1

Cannula - 07290014954106 Catalog Number : STR-021621-00

Device Description : Sterile Nexframe/Starfix Stainless Steel Guide Tube (cannula) and Stylet

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroNav Input Cable - 07290014954113 Catalog Number : STR-000526-11

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NeuroNav Input Cable - 07290014954120 Catalog Number : STR-000526-22

Device Class : 2

Duns Number: 531856466

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

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