Catalog Number

-

Brand Name

Nellcor

Version/Model Number

DSPM10N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 04, 2020

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

K141542

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

596f4c11-0111-4b03-9423-b937f24c86be

Public Version Date

April 18, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-