Duns Number:013029698
Catalog Number
-
Brand Name
Body fat scale
Version/Model Number
SW-SBS500
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
K102191,K102191,K102191
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
64d5dac3-24cd-47fc-b4b2-a25c3bb7f92a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 18, 2016
Package DI Number
00817746020311
Quantity per Package
1
Contains DI Package
00817746020304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |