ZEUS Platform (FG0501US)
510(k) K252859
ZEUS Platform (FG0501US) is a Class II device made by Irhythm Technologies, Inc., cleared under FDA 510(k) K252859 on 29 May 2026, 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 | NumberK252859 | Date29 May 2026 | StatusActive |
Official records
- FDA 510(k) database K252859
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- Withdrawn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
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