Duns Number:757258843
Device Description: DF50 Body Composition Analysis Software
Catalog Number
292-DF50CD
Brand Name
Body Composition Analysis Software
Version/Model Number
4.1.2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 2017
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
K050395,K050395,K050395
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
0d9dff0e-c073-4d8d-bcaa-d81793fd3290
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
B277292DF50CD1
Quantity per Package
1
Contains DI Package
B277292DF50CD0
Package Discontinue Date
December 31, 2016
Package Status
Not in Commercial Distribution
Package Type
Software CD
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 20 |