SOZO
FDA 510(k) clearance K180126 · decided 2018-04-16
Clearance details
- K-number
- K180126
- Device name
- SOZO
- Applicant
- ImpediMed Limited
- Decision
- Substantially Equivalent
- Date received
- 2018-01-16
- Decision date
- 2018-04-16
- Days to decision
- 90 days
- Clearance type
- Traditional
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SOZO Bilateral Arm L-Dex Software recall (Z-0155-2024) | Impedimed Limited | 2023-10-24 |