← Back to catalogue

Apk

FDA UDI

Class II (US FDA UDI)

by Apk Technology

Identity

Trade Name
APK FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
BIOSYS Compatible Reusable SpO2 Sensor FDA UDI
Model / Reference
A0219-SW123PU FDA UDI
Description
BIOSYS Compatible Reusable SpO2 Sensor FDA UDI

Identifiers

Primary DI / UDI-DI
06946725525722 FDA UDI
510(k) Number
K082846 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter probe, reusable 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

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

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K082846 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Apk Technology

Sources (1)

  • FDA UDI aaa71fb0-b25d-4213-9a8b-209ec5f1acb3 34 fields · synced May 30, 2026