Catalog Number

-

Brand Name

O2Health fingertip pulse oximeter

Version/Model Number

DB11-B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122927

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

e33e811d-33ec-48e5-890a-1e5492e6972a

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

April 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-