Catalog Number

-

Brand Name

Wireless Pulse Oximeter

Version/Model Number

WPO-10B

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170965

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

2c88de82-5ba7-4860-9538-7aaa7ca61183

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

June 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-