Bodystat - Bodystat 1500 Body Composition Monitoring Unit - BODYSTAT LTD

Duns Number:232767004

Device Description: Bodystat 1500 Body Composition Monitoring Unit using Bioelectrical Impedance Analysis (BIA Bodystat 1500 Body Composition Monitoring Unit using Bioelectrical Impedance Analysis (BIA)

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More Product Details

Catalog Number

-

Brand Name

Bodystat

Version/Model Number

1500

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082253

Product Code Details

Product Code

MNW

Product Code Name

Analyzer, Body Composition

Device Record Status

Public Device Record Key

aa1cecd2-1579-47f1-9341-60a29c02c762

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BODYSTAT LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6