Catalog Number

-

Brand Name

FLUOBEAM 800

Version/Model Number

FB800-CL v1.8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132475

Product Code

OWN

Product Code Name

Confocal Optical Imaging

Public Device Record Key

0fe2980a-b011-4e05-a213-3d0da8c26da3

Public Version Date

February 01, 2022

Public Version Number

4

DI Record Publish Date

April 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-