Catalog Number

-

Brand Name

N/A

Version/Model Number

8225490E

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

Yes

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

K024316

Product Code

IKN

Product Code Name

Electromyograph, diagnostic

Public Device Record Key

ac050fcb-6cdd-40f7-91f0-9ec3cad75971

Public Version Date

April 12, 2019

Public Version Number

1

DI Record Publish Date

April 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-