Catalog Number

-

Brand Name

Fundus Camera

Version/Model Number

SK-650A

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

-

Product Code

PJZ

Product Code Name

Camera, Ophthalmic, General-Use

Public Device Record Key

bf2a12e9-b115-4dcc-9a75-a08a9077dff1

Public Version Date

July 10, 2020

Public Version Number

1

DI Record Publish Date

July 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-