KONAN MEDICAL USA, INC.

Address:15770 Laguna Canyon Road,Irvine,CA,92618,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) Pupillograph (HRI) (1) Stimulator, photic, evoked response (GWE) (1)

Premarket Exempt

No Yes

Clear

NA - 04582275270020 Catalog Number :

Device Class : 2

Duns Number: 788439219

Premarket Exempt : No

Product Code : GWE

Prescription Use : No

Device Count : 1

NA - 04582275270037 Catalog Number :

Device Class : 2

Duns Number: 788439219

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

NA - 04582275270044 Catalog Number :

Device Class : 2

Duns Number: 788439219

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

N/A - 04582275270051 Catalog Number :

Device Class : 1

Duns Number: 788439219

Premarket Exempt : Yes

Product Code : HRI

Prescription Use : No

Device Count : 1

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