Catalog Number

760.71

Brand Name

Beurer

Version/Model Number

BF520

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110928,K110928

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

f726045b-15bd-441b-a529-e0ad46b8a8b3

Public Version Date

October 25, 2019

Public Version Number

1

DI Record Publish Date

October 17, 2019

Package DI Number

10852547004181

Quantity per Package

3

Contains DI Package

00852547004184

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack