Duns Number:757258843
Device Description: SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real- SOZO Body Fluid Analyzer working in conjunction with SOZOapp 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 dry electrode, and displaying the results on a monitor. (Repackaged for use in Clinical evaluations (Trials))
Catalog Number
2826995
Brand Name
SOZO Body Fluid Analyzer
Version/Model Number
2826995
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172122,K172122
Product Code
OBH
Product Code Name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Public Device Record Key
6f1b62e1-91ae-4c92-bea5-4c6d61a818cf
Public Version Date
May 24, 2022
Public Version Number
1
DI Record Publish Date
May 16, 2022
Package DI Number
B27728269951
Quantity per Package
1
Contains DI Package
B27728269950
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |