Duns Number:757258843
Device Description: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radi BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor.ROW New-Device
Catalog Number
229-SFB7
Brand Name
Imp SFB7
Version/Model Number
SFB7
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K052319,K052319,K052319
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
00f75b8a-20d3-4c9a-9d37-0f61a3ca6669
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
B277229SFB72
Quantity per Package
1
Contains DI Package
B277229SFB71
Package Discontinue Date
-
Package Status
-
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |