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Apk

FDA UDI

Class II (US FDA UDI)

by Apk Technology

Identity

Trade Name
APK FDA UDI
Generic Name
Pulse Co-oximeter probe, single-use FDA UDI
Device Name
Disposable SpO2 sensor compatible with RD SET Pediatric Non-woven FDA UDI
Model / Reference
A1315-SP03 FDA UDI
Description
Disposable SpO2 sensor compatible with RD SET Pediatric Non-woven FDA UDI

Identifiers

Primary DI / UDI-DI
06946725540206 FDA UDI
510(k) Number
K082846 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse Co-oximeter probe, 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse Co-oximeter probe, single-use

Apk by Apk Technology — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse Co-oximeter probe, single-use.

Cleared under the same submission

K082846 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apk Technology

Sources (1)

  • FDA UDI ab8232e6-016e-46a5-be49-232ba8e24010 34 fields · synced May 31, 2026