VIOPTIX, INC.

Address:39655 Eureka Dr,Newark,CA,94560,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

Oximeter, Tissue Saturation (MUD) (5)

Premarket Exempt

Clear

Intra.Ox Smart Sensor - B426OXY2DUR10 Catalog Number : OXY-2-DUR-1

Device Class : 2

Duns Number: 127211923

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

Intra.Ox Optical QC Target - B426OXY2QCT10 Catalog Number : OXY-2-QCT-1

Device Class : 2

Duns Number: 127211923

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

T.Ox SP Sensor - B426OXY2SPD10 Catalog Number : OXY-2-SPD-1

Device Class : 2

Duns Number: 127211923

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

T.Ox SS Sensor - B426OXY2SPI10 Catalog Number : OXY-2-SPI-1

Device Class : 2

Duns Number: 127211923

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

Intra.Ox Disposable Sheath - B426OXY2STH10 Catalog Number : OXY-2-STH-1

Device Class : 2

Duns Number: 127211923

Premarket Exempt : No

Product Code : MUD

Prescription Use : Yes

Device Count : 1

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