SOZO
FDA 510(k) clearance K172122 · decided 2017-08-11
Clearance details
- K-number
- K172122
- Device name
- SOZO
- Applicant
- ImpediMed Limited
- Decision
- Substantially Equivalent
- Date received
- 2017-07-13
- Decision date
- 2017-08-11
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- OBH
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pinkenba, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) (K253224) | ImpediMed Limited | 2026-01-28 |
| SOZO Pro (K230530) | ImpediMed Limited | 2023-05-04 |
| MoistureMeterD Compact, LymphScanner (K220557) | Delfin Technologies, Ltd. | 2022-05-27 |
| SOZO (K180126) | ImpediMed Limited | 2018-04-16 |
| MoisturemeterD (K143310) | Delfin Technologies, Ltd. | 2015-11-19 |
| IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS (K130338) | ImpediMed Limited | 2013-05-31 |
| IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (K100811) | ImpediMed Limited | 2011-11-04 |
| IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 (K080825) | Impedimed Pty , Ltd. | 2008-10-03 |
| IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS (K050415) | Impedimed Pty , Ltd. | 2007-03-30 |
Recalls involving this device
No recalls on record reference this clearance.