Catalog Number

-

Brand Name

Nellcor

Version/Model Number

DSPM1000N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 28, 2019

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K141518

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

496cf864-ebc5-4aad-9dcd-674939de09b8

Public Version Date

August 31, 2022

Public Version Number

7

DI Record Publish Date

July 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-