Catalog Number

-

Brand Name

InBody

Version/Model Number

InBody370S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 30, 2017

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

K130777

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Public Device Record Key

079fc434-729f-44a3-9943-95bea557ad64

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-