Catalog Number

-

Brand Name

Narcotrend Patient lead

Version/Model Number

PKM4

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

K033543

Product Code

OLT

Product Code Name

Non-Normalizing Quantitative Electroencephalograph Software

Public Device Record Key

6a7bda63-cf65-47a6-ac31-79266df12512

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-