Sozo
by Impedimed Limited 4 variants
510(k) K172507
Sozo is a Class II device made by Impedimed Limited, cleared under FDA 510(k) K172507 on 22 Dec 2017, 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 | NumberK172507 | Date22 Dec 2017 | StatusActive |
Official records
- FDA 510(k) database K172507
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- Withdrawn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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