L K C TECHNOLOGIES, INC.

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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, Photic, Evoked Response (GWE) (8) Electrode, Cutaneous (GXY) (2)

Premarket Exempt

Clear

UTAS - 00857901006538 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006545 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006552 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006569 Catalog Number :

Device Description : 4CH/AC, BigShot, UV, CRT

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006576 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006583 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006590 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006606 Catalog Number :

Device Description : 6CH Pattern/Multi-Focal Only

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

RETeval™ - 10857901006009 Catalog Number : Sensor Strips

Device Description : Box of 50 pairs (1-right & 1-left per pair) of electrodes for use with the RETev Box of 50 pairs (1-right & 1-left per pair) of electrodes for use with the RETeval visual electrophysiology system.

Device Class :

Duns Number: 606234730

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 50

RETeval™ - 10857901006313 Catalog Number : Sensor Strips

Device Description : Bag of 25 pairs (1-right & 1-left per pair) of Small electrodes for use with the Bag of 25 pairs (1-right & 1-left per pair) of Small electrodes for use with the RETeval visual electrophysiology system.

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 25

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