Catalog Number

-

Brand Name

neo

Version/Model Number

LE-800

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K192889

Product Code

OMA

Product Code Name

Amplitude-integrated electroencephalograph

Public Device Record Key

2a2377f1-74ab-470b-a6d5-4b36d34c93ca

Public Version Date

March 05, 2020

Public Version Number

1

DI Record Publish Date

February 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-