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)
Catalog Number
-
Brand Name
Bodystat
Version/Model Number
1500
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082253
Product Code
MNW
Product Code Name
Analyzer, Body Composition
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |