SOZO
FDA 510(k) clearance K190529 · decided 2019-11-25
Clearance details
- K-number
- K190529
- Device name
- SOZO
- Applicant
- ImpediMed Limited
- Decision
- Substantially Equivalent
- Date received
- 2019-03-04
- Decision date
- 2019-11-25
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- QJB
- 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 |
|---|---|---|
| SOZO Pro (K230531) | ImpediMed Limited | 2023-05-04 |
Recalls involving this device
No recalls on record reference this clearance.