Catalog Number

-

Brand Name

Ziehm Vision FD

Version/Model Number

302891; 302929

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K193230

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Public Device Record Key

48f986ce-0866-4ac4-8e7e-d9c9737c9a29

Public Version Date

March 20, 2020

Public Version Number

1

DI Record Publish Date

March 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-