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.
Catalog Number
2727000
Brand Name
SOZO Body Fluid Analyzer
Version/Model Number
2727000
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,K172122
Product Code
OBH
Product Code Name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Public Device Record Key
17ae8051-57b8-4919-8fe6-b173a52d064d
Public Version Date
September 20, 2019
Public Version Number
1
DI Record Publish Date
September 12, 2019
Package DI Number
B27727269951
Quantity per Package
1
Contains DI Package
B27727269950
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |