Catalog Number

-

Brand Name

Cascade IOMAX Intraoperative Monitor

Version/Model Number

190291-200

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

K162199

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

bfc19c0d-7c2a-47f9-9b02-0f8c9cd664dc

Public Version Date

April 15, 2019

Public Version Number

5

DI Record Publish Date

May 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-