InBody - Body Composition Analyzer - InBody Co., Ltd.

Duns Number:688003404

Device Description: Body Composition Analyzer

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More Product Details

Catalog Number

-

Brand Name

InBody

Version/Model Number

InBody270

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K092786

Product Code Details

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Device Record Status

Public Device Record Key

194b96fe-4082-4481-918a-7a4b963831b9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INBODY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21