Catalog Number

-

Brand Name

Mespere

Version/Model Number

OS-NeurOs

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K182242

Product Code

MUD

Product Code Name

Oximeter, Tissue Saturation

Public Device Record Key

cde8322e-f06c-4eac-9685-7e249bba34b8

Public Version Date

February 28, 2019

Public Version Number

1

DI Record Publish Date

January 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-