Sozo
by Impedimed Limited 4 variants
510(k) K203473
Sozo is a Class II device made by Impedimed Limited, cleared under FDA 510(k) K203473 on 19 Apr 2021, 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 | NumberK203473 | Date19 Apr 2021 | StatusActive |
Official records
- FDA 510(k) database K203473
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- Withdrawn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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