Catalog Number

-

Brand Name

Laser Speckle Flowgraphy LSFG-NAVI

Version/Model Number

LSFG-NAVI-NM2

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

K153239

Product Code

HLI

Product Code Name

Ophthalmoscope, Ac-Powered

Public Device Record Key

70d09bf1-306a-4de6-af89-943c7a2d5ad6

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

February 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-