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T.Ox SP Sensor

FDA UDI

Class II (US FDA UDI)

by Vioptix, Inc.

Identity

Trade Name
T.Ox SP Sensor FDA UDI
Generic Name
Tissue saturation oximeter sensor, single-use FDA UDI
Model / Reference
OXY-2-SPD-1 FDA UDI

Identifiers

Catalog Number
OXY-2-SPD-1 FDA UDI
Primary DI / UDI-DI
B426OXY2SPD10 FDA UDI
510(k) Number
K042657 FDA UDI
K141234 FDA UDI
FDA Product Code
MUD FDA UDI
GMDN Term
Tissue saturation oximeter sensor, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tissue saturation oximeter sensor, single-use

T.Ox SP Sensor by Vioptix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue saturation oximeter sensor, single-use.

Cleared under the same submission

K042657 also covers:

K141234 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vioptix, Inc.

Sources (1)

  • FDA UDI a796a55d-721b-42b9-8218-4224b472d299 35 fields · synced Jun 1, 2026