Catalog Number

293-SFB7CD

Brand Name

BioImp Body Composition Analysis Software SFB7

Version/Model Number

5.5.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K052319,K052319

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

5f1628bd-7aa5-4b1e-bf83-d9b034892322

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

B277293SFB7CD1

Quantity per Package

1

Contains DI Package

B277293SFB7CD0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CD Sleeve