Catalog Number

-

Brand Name

LeSono

Version/Model Number

LU700

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2021

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

K191235

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

734aba36-2127-4d75-b4d6-4a0ad205c6fa

Public Version Date

March 11, 2021

Public Version Number

3

DI Record Publish Date

January 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-