SOZO Pro
by Impedimed Limited 3 variants
510(k) K232089
SOZO Pro is a Class II device made by Impedimed Limited, cleared under FDA 510(k) K232089 on 17 Oct 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232089 | Date17 Oct 2023 | StatusActive |
Official records
- FDA 510(k) database K232089
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSB
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2770
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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