ZIO XT Patch N100A102X
ZIO XT Patch N100A102X is a Class II device made by Irhythm Technologies, Inc., cleared under FDA 510(k) K121319 on 18 Jul 2012 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00869770000203), 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 | GUDID listing | Number00869770000203 | Date19 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121319 | Date18 Jul 2012 | StatusActive |
Official records
- AccessGUDID record 00869770000203
- FDA 510(k) database K121319
Across registries
- FDA 510(k) K121319 decided 18 Jul 2012 Active
- FDA GUDID UDI-DI 00869770000203 listed 19 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K121319
- Listed FDA GUDID 00869770000203
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ZIO XT Patch
- Generic name
- Electrocardiographic ambulatory recorder
- Model / reference
- N100A102X
- Primary DI / UDI-DI
- 00869770000203
- 510(k) Number
- FDA product code
- DSH
- GMDN term
- Electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.2800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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