Catalog Number

-

Brand Name

Nihon Kohden

Version/Model Number

A0001D06-001

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

K170536

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

e74f2d2b-5124-4053-80e5-b5feb07f09ef

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-