Catalog Number

000385

Brand Name

Optos OCT/SLO

Version/Model Number

OCT

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

K080460

Product Code

OBO

Product Code Name

Tomography, Optical Coherence

Public Device Record Key

b96bd9d0-06e9-4eb8-9878-3a7b66a0cad8

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-