Catalog Number

-

Brand Name

Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz

Version/Model Number

B9700041001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K073415

Product Code

IKN

Product Code Name

Electromyograph, Diagnostic

Public Device Record Key

7fcc57bb-bb88-464e-8350-efed3fea45de

Public Version Date

June 03, 2019

Public Version Number

1

DI Record Publish Date

May 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-