Zio Patch
by Irhythm Technologies, Inc. 2 variants
510(k) K121319
Zio Patch is a Class II device made by Irhythm Technologies, Inc., cleared under FDA 510(k) K121319 on 18 Jul 2012, 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 | NumberK121319 | Date18 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K121319
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSH
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K121319
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 XT Patch N100A102X | N100A102X | 00869770000203 | — | On the market |
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