FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
K Number: K253224
·
Decision Jan 28, 2026
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
9
Applicant Total
12
Review Days
121
Basic Information
- Device Name
- MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
- K Number
- K253224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ImpediMed Limited
- Date Received
- September 29, 2025
- Decision Date
- January 28, 2026
- Product Code
- OBH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | FDA class 2 | Cardiovascular |
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Other Clearances by ImpediMed Limited
| K Number | Device Name | ||
|---|---|---|---|
| K232089 | SOZO Pro | Oct 17, 2023 | Substantially Equivalent |
| K230530 | SOZO Pro | May 4, 2023 | Substantially Equivalent |
| K230531 | SOZO Pro | May 4, 2023 | Substantially Equivalent |
| K203473 | SOZO | Apr 19, 2021 | Substantially Equivalent |
| K193410 | SOZO Body Fluid Analyzer | Oct 2, 2020 | Substantially Equivalent |
| K190529 | SOZO | Nov 25, 2019 | Substantially Equivalent |
| K180126 | SOZO | Apr 16, 2018 | Substantially Equivalent |
| K172507 | SOZO | Dec 22, 2017 | Substantially Equivalent |
| K172122 | SOZO | Aug 11, 2017 | Substantially Equivalent |
| K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | May 31, 2013 | Substantially Equivalent |