ZEUS System
510(k) K222389
ZEUS System is a Class II device made by Irhythm Technologies, Inc., cleared under FDA 510(k) K222389 on 15 Feb 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 | NumberK222389 | Date15 Feb 2023 | StatusActive |
Official records
- FDA 510(k) database K222389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K222389
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Zio ECG Utilization Software (ZEUS) System FG0401US | FG0401US | 00850043907046 | — | On the market |
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