510(k) K253224
- Device
- MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
- Applicant
- ImpediMed Limited
- 510(k) number
- K253224
- Product code
- OBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-28
- Date received
- 2025-09-29
- Regulation
- 870.2770
- Classification name
- Monitor, Extracellular Fluid, Lymphedema, Extremity
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Richard Hines
- Address
- Unit 1 50 Parker Ct. Pinkenba Pinkenba AU 4008 4008
FDA Registration Numbers
- 3004782476
- 3003857828
- 3003695829
- 3004896338
- 3005699942
Source Documents
Other 510(k) Records For Product Code OBH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230530 | SOZO Pro | ImpediMed Limited | 2023-05-04 |
| K220557 | MoistureMeterD Compact, LymphScanner | Delfin Technologies, Ltd. | 2022-05-27 |
| K180126 | SOZO | ImpediMed Limited | 2018-04-16 |
| K172122 | SOZO | ImpediMed Limited | 2017-08-11 |
| K143310 | MoisturemeterD | Delfin Technologies, Ltd. | 2015-11-19 |
| K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | ImpediMed Limited | 2013-05-31 |
| K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | ImpediMed Limited | 2011-11-04 |
| K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | Impedimed Pty , Ltd. | 2008-10-03 |
| K050415 | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS | Impedimed Pty , Ltd. | 2007-03-30 |