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) (10)

Premarket Exempt

Clear

UTAS - 00857901006200 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006217 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006224 Catalog Number : UTAS

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006231 Catalog Number :

Device Description : 4-channel AC Coupled UBA

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

UTAS - 00857901006248 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006255 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006262 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006279 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006286 Catalog Number :

Device Class : 2

Duns Number: 606234730

Premarket Exempt : No

Product Code : GWE

Prescription Use : Yes

Device Count : 1

UTAS - 00857901006293 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

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